[UPDATE] Resolution of the German Bundesrat - Urgent need for action in the implementation of the European Medical Devices Regulation (MDR)

The German Länder urge the Federal Government of Germany to take action at the EU level regarding the imminent problems with the implementation of EU Medical Device Regulations.

 

The Decision 445/22 published on 07.10.2022 summarizes the concerns of the German Länder. See the official publication in German here, and Medidee's tentative translation to English below:

 

2022-10-09 Summary and tentative translation – Bundesratsbeschluss Oct07-2022

 

To make sure that your transition to MDR is as quick and smooth as possible, contact Medidee today: www.medidee.com/contacts


Business Case Fabrinal Medidee - Eye

[Business Case] How the long-term collaboration between Fabrinal and Medidee supports the competitiveness of the Swiss Manufacturer

This Business Case introduces the collaboration between Fabrinal, an SME focused on medical technology applied to studying the eye, and Medidee, a global regulatory service provider active in the fields of Medical Devices and IVD products.

 

Fabrinal has been supported closely for almost 10 years by Medidee. For an SME of our size, this change is so critical from a timing and economic point of view, that it is crucial to be advised by rational and experienced experts. I am extremely confident about their advice and application of the MDR and can navigate through this challenging change a bit less worried.

 

Cloé Houriet, CEO of Fabrinal

 

Read more about the Regulatory challenges faced by Fabrinal and how Medidee supported overcoming them:

 

Business Case – MDR Transition – Fabrinal & Medidee

 

Click to learn more about how Medidee supports your MDR Transition


Cybersecurity Medical Devices

Artificial Intelligence (AI), General Data Protection Regulation (GDPR) and Cybersecurity: 10 Misconceptions about Medical Device Software

Artificial Intelligence (AI), General Data Protection Regulation (GDPR) and Cybersecurity: 10 Misconceptions about Medical Device Software

 

Medical Device Software (MDSW) is a growing, fast-evolving industry. However, manufacturers often must face a regulatory framework which does not evolve at the same speed. Regulation for medical devices is restrictive, since it needs to guarantee the safety of users (e.g. Health Care Professionals) and the target population (e.g. patients). Moreover, it has experienced a significant increase in requirements with the approval of the new regulation MDR 2017/745. Manufacturers of MDSW who have never placed a medical device on the market, or who did it under the former Medical Device Directive (93/42/EEC MDD) might have some misconceptions about the process. The purpose of this article is to address some of the most common (and not always right) assumptions and provide useful and truthful information about the process of reaching the conformity assessment under MDR, for successfully placing an MDSW on the market. 

 

Cybersecurity Medical Devices

Here are 10 common misconceptions about Medical Device Software, and their respective clarification:

 

1. MDSW is classified as low risk under the MDR 2017/745. 

False! On the contrary, only a small portion of MDSW is classified with the lowest risk class (class I) according to the new regulation (MDR2017/745 annex VIII) and related guideline (MDCG 2019-11). To classify a Medical Device Software, two main aspects must be taken into account: 1) the severity of the state of the healthcare situation or patient condition and 2) the significance of the information provided by the software to the healthcare situation related to diagnosis/therapy. After taking these factors into consideration, most MDSW is classified in higher classes, from Class IIa to Class III, which entails increased regulatory requirements. 

 

2. Agile development practice and IEC 62304 requirements cannot co-exist because they rely on fundamentally conflicting principles. 

Agile methodologies (i.e. SCRUM) are compatible with the standard for the development of Medical Device Software. Actually, there exists a Technical Information Report providing guidance on the use of Agile practices in the development of medical device software (AAMI TIR45:2012). It is up to the manufacturer to decide the Software Development Lifecycle (SDLC) of the product. However, there are multiple challenges that a manufacturer must face, especially in terms of procedures (alignment with the Quality Management System), validation of tools and documentation.

 

3. I have developed a Machine Learning model that underwent thorough testing and showed excellent technical performance, so I should be able to access the market in a few months. 

All MDSW embedding AI must comply with applicable MDR 2017/745 requirements prior to being placed on the market. This means that the processes and the timing to access the market are not accelerated compared to other medical devices. In addition to the general regulation, there are some relevant specific considerations for the Clinical Evaluation of Medical Device Software as per MDCG 2020-1: For any MDSW (including AI-based MDSW), Clinical Evaluation should demonstrate the valid clinical association/scientific validity, technical performance, and clinical performance. This guidance on clinical evaluation of MDSW provides a framework for the determination of the appropriate level of clinical evidence required for MDSW. The provisions of this guidance document should be taken into consideration from the early stages of software development.

 

4. I can place my AI-based Software Medical device on the market if I have trained, tested and validated it with datasets coming from open access repositories.  

It depends. It is important to verify that sufficient information is available on the origin of the clinical data. Multiple requirements might be fulfilled to ensure the validity of the protocol used to collect the data as well as the compliance of the data collection methods with GDPR: Was the study run according to the Good Clinical Practices and standards? Was GDPR followed? Was the data collection performed by certified professionals? It is also important to adopt good machine learning practices during model training, testing and validation, e.g., that training and testing datasets should be independent. For more information, check these guiding principles for Good Machine Learning Practices. 

 

5. If my MDSW fails to ensure personal data protection, it is not considered as harm. 

According to the MDR 2017/745, all parties involved in its application shall respect the confidentiality of information and data obtained. Even if the failure of the software does not result in a lesion or physical injury, disclosure of personal yields infringement penalties according to MDR2017/745 and GDPR Regulation (EU) 2016/679. Therefore, data processing, involving transmission over a network or storage needs to be properly tackled by design strategies (e.g. minimum data collection, pseudo anonymisation) and complemented with ICT techniques (encryption, Secure layers, etc.). To conduct Risk management is a “must”, and any residual risk must be mitigated as much as possible.

6. If my device is not storing data, I do not need to comply with GDPR.

Even if the device does not store data, it still might be, for instance, linked to a website that collects some personal information related to the user or the practitioner. It is important to conduct an analysis of the whole lifecycle of the product and identify which processes need special attention as per the GDPR requirements. 

 

7. If I am working with anonymised data, I do not need to comply with GDPR. 

That is true if data is completely anonymised. However, most manufacturers rather work with pseudo-anonymised data, meaning that there is a “key” that can be used to link back the clinical data with the personal information of the patient. In this case, the manufacturer needs to be compliant with GDPR regulations. 

 

8. I can keep the collected data for as long as I want. 

Similarly, that depends on whether the collected data is fully anonymised. If that is the case, there are no time restrictions for its storage, but if the data is pseudo-anonymised, there are restrictions. GDPR regulation does not establish specific time windows within which the storage is allowed, instead, it mentions that “personal data must be kept in a form that makes it possible to identify data subjects for no longer than is necessary for the purposes of the processing”. 

 

9. If I use a cloud server, I do not need to worry about cybersecurity because the service provider takes care of it. 

Be careful, most cloud servers are not specifically designed to host confidential data or clinical data. When choosing a cloud server for such purposes, it is good to select an ISO 27001 certified provider. That means that the provider has a model for establishing, implementing, operating, monitoring, reviewing, maintaining and improving an information security management system. However, be proactive! Use all relevant information sources (Common Vulnerabilities and Exposures (CVE) for vulnerability monitoring, testing tools such as Trivy, Shodan, OWASP, etc.), and monitor all processes concerning maintenance and infrastructure via health checks.  

 

10. If the Software Medical Device is a standalone software intended to be used in a host, I do not need to take precautions on cybersecurity. 

False! MDR 2017/745 requires manufacturers to foresee possible threats caused by misuse of their device and to take actions to prevent it. Besides, MDR also requires reducing as far as possible the risk associated with the possible negative interaction between software and the IT environment the MDSW operates and interacts with. So, it is important to take cybersecurity preventive measures to identify possible threats, vulnerabilities, assets and impacts. A manufacturer needs to consider security in a holistic approach as the nature of assets is diverse: Hardware (including the infrastructure), Software (protection against most common threats such as ransomware, malware, legacy software, Software of Unknown Provenance, etc), Data (Personal Identifiable Information PII, Health Records, Systems configuration, etc), and Users (considering misuse, unauthorised users, protection of sensitive functionalities, etc). 

 

 

Placing MDSW on the market requires knowledge of a broad variety of topics, including regulation and related guidelines for clinical validation, GDPR, cybersecurity, risk management and quality control. 

 

With an extensive track record working on similar problematics, Medidee can support you with services ranging from training courses and coaching, up to completing the strategy to successfully bring your product to the market.

 

Contact us today to discuss your project! 

 

 

This article was written by Dr Nuria Gresa, Dr Stamatia Pagoulatou and Dr Gustavo Hernandez.


MDR Technical Documentation Infographic

[ARTICLE] Why You Need To Review Your Technical Documentation NOW (And 8 Pitfalls to Avoid at all Costs)

According to the Medical Device Survey 2021 by The European Association for Medical devices of Notified Bodies, Medical Device (MD) companies who have applied for MD Regulation (MDR 2017/754) certification remain a minority (only 26.3% had applied at the end of 2021). A lot of applications are yet to be received!

 

Bottleneck for Technical Documentation (TD) review by Notified Bodies (NB) is a reality

 

With increased requirements to comply with MDR and a decreased number of Notified Bodies being able to deliver certificates under those regulations (from 50 down to 32 as of August 1st), it gets longer and longer to obtain a certification.

 

Currently, from the positive outcome of the Completeness Check, it takes between 6 (low-risk devices) and 24 months (high risk)until the issuance of the MDR certificate. Knowing that certificates issued under the MDD/AIMDD remain valid until May 2024 at the latest, waiting too long before submitting your Technical Documentation can result in having no valid certificate to operate in the market.

 

MDR Technical Documentation Infographic

 

How to speed up the certification process: be right the first time!

 

The requirements under MDR are more stringent compared to previous directives. A thorough gap analysis of your Technical Documentation needs to be performed at first to identify the (possibly) missing documents to demonstrate compliance against all General Safety and Performance Requirements (GSPR). Additional device testing might also be required which will significantly delay the moment of application to a NB.

 

Indeed, with the implementation of the Completeness Check process, at least 50% of the TD submitted are deemed incomplete, and NB request additional information to start the assessment according to the Medical Device Survey 2021. These numbers are confirmed by two other surveys published very recently by the European Commission and MedTech Europe.

 

Considering these timelines, you cannot afford to wait for the initial feedback from the Notified Body to discover deficiencies in your Technical Documentation – you really need to be right the first time, avoiding common pitfalls.

8 Technical Documentation pitfalls to avoid at all costs

 

Having performed many gap analyses regarding TD compliance against MDR, as well as having accompanied several companies through MDR transition, Medidee has a clear vision of the main pitfalls throughout this process. Below are typical examples of which companies should be aware before submission. If you would like to learn more about this topic, don't miss the chance to watch our on-demand webinar:

 

Technical documentation webinar

Pitfall 1: Your TD is not well organized

 

A clear structure throughout the technical documentation is helpful in ensuring that the reviewing body can clearly understand the contents. The MDR now provides, in Annexes II and III, detailed instructions on what is the minimum content of technical documentation, also defining a specific structure for it.

 

Pitfall 2: No identifiable thread within your TD

 

Manufacturers shall maintain traceability from the User Requirements Specification (URS) to the Functional Requirements Specification (FRS), risk analysis, clinical evaluation and the GSPR. This is key to demonstrating full compliance to GSPR.

 

Pitfall 3: Negligence of Post Market Surveillance data

 

Manufacturers of devices, even those that have been on the market for many years, need to collect or complete a review of existing Post-Market Surveillance (PMS) data, to be able to cover the requirements related to clinical evaluation, as set out by Article 61 of the MDR. For devices that have previously been placed on the market, this includes, but is not limited to the Post Market Clinical Follow Up (PMCF) data, vigilance data, user feedback and complaints.

 

Pitfall 4: No anticipation of risk class changes for your device

 

Although this applies to all MDs, it is particularly true for Software as Medical Device (SaMD). Indeed, the classification rule 11 from MDR, and related MDCG guideline MDCG 2019-11, lead to a class upgrade: 80% of the SaMD which did not need a NB before MDR implementation do require one now. This leads to a tremendous change in the company’s organization to obtain a certificate, while also adding to the above-mentioned bottleneck effect.

 

Pitfall 5: Not enough precision on how GSPR compliance is reached

 

Manufacturers must provide suitable objective evidence to show that their device satisfies the requirements detailed in Annex I of the MDR GSPRs. Where manufacturers determine that specific GSPRs are not applicable to their device, “an explanation as to why [they] do not apply” must be provided, which is a new requirement in the MDR (Annex II, point 4(a)). Moreover, pointing precisely to the key documents demonstrating compliance to each GSPR will simplify the TD review by the NB as well as help you identify possible gaps within your own TD before submission.

 

Pitfall 6: No implementation readiness documentation of the UDI traceability system

 

The Unique Device Identification (UDI) system has a direct impact on the labelling, artwork, and DoC, as manufacturers will need to place a UDI carrier on the label of the device and on all higher levels of packaging, except the shipment packaging (Article 27, point 4). Your quality management system will also need to be aligned to the UDI system implementation. Beware to anticipate any risk linked to the UDI system implementation within your Risk Management file.

 

Pitfall 7: Absence of specific information relating to device design and history

 

For all classes of medical devices, manufacturers must now provide, as per Annex II, information in the technical documentation to explain the design stages and procedures that are applied to their device (Annex II, point 3). Under the requirements of the MDD/AIMDD, this was only the case for class III devices. Therefore, depending on the classification of the device, manufacturers may need to update the content of the technical documentation.

 

Pitfall 8: Person Responsible for Regulatory Compliance (PRRC) not designated early enough within your organization

 

Article 15 of the MDR clearly stipulates the obligation for medical device manufacturers to have available, within their organization (or permanently and continuously at their disposal for micro and small companies), at least one person, possessing the necessary expertise in the field of medical devices, who is responsible for regulatory compliance. Among other responsibilities, the person or people responsible for regulatory compliance must ensure that the technical documentation is compiled and maintained.

 

 

Medidee: Easying your MDR transition with services tailored to your needs

 

From a simple gap analysis to guide you towards the appropriate tests or data reviews needed, to performing those reviews, building test protocols, writing test reports or consolidating the entire TD, Medidee’s team of experts is ready to support you in this process.

 

Having accompanied many companies in the transition to MDR, Medidee has gained experience and is able to make this transition as smooth as possible for your organization.

 

Do not wait any longer! Learn more about our MDR Transition service and contact us today to kick-start your own MDR transition!

 

This article was written by Dr Lydie Moreau.


Article - Electrical Safety - Medidee Services

[ARTICLE] Electrical Safety: How changes to IEC 60601 Series trigger additional testing for your device (IEC 60601-1, Edition 3.2)

This article is the first one of a series about IEC 60601. It contains insightful information about IEC 60601-1 Edition 3.2, with a similar structure as the second article.

 

The latest amendment of IEC 60601-1 for medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1 Edition 3.2) was published on 2020-08-20 by the International Electrotechnical Commission (IEC). Edition 3.2 notably addresses issues raised by national committees and questions submitted to IEC/SC 62A/Working Group 14 with regards to previous version 3.1.

 

Since the 30th of May 2022, the United States Food & Drug Administration (FDA) has listed IEC 60601-1 3.2 Edition for Medical Electrical Equipment – Part 1: General requirements for basic safety and essential performance as a recognized standard (FDA recognition number 19-46). IEC 60601-1 3.2 Edition will replace the current listed IEC 60601-1 3.1 Edition (FDA recognition number 19-4) by the 17th of December 2023. Until this date, FDA will accept declarations of conformity referring to IEC 60601-1 3.1 Edition, in support of premarket submissions.

 

To date, no announcement relative to an official transition period for the applicability of Edition 3.2 or to its harmonization under the Medical Device Directive (93/42/EEC) or Medical Device Regulation (EU 2017/745) has been issued in the official journal of the European Union. As per the list of recognized consensus standards of the Food & Drug Administration (FDA), ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) are currently listed.

 

In the absence of any official communication within the European Union on the matter, it is anticipated that manufacturers will be granted a transition period of 3 to 4 years after the date of publication, before they will be expected to demonstrate compliance with the applicable new requirements introduced by the amended standard.

 

Medidee has observed that manufacturers of electrically driven active medical devices are commonly unaware of the latest revision of this standard and consequently of the new requirements it entails. This article aims to raise awareness of this amendment of IEC 60601-1, to summarize the main changes compared to the previous version of the standard, and to illustrate through a few examples how these changes may affect manufacturers of medical electrical equipment and systems.

 

What are main the differences between IEC 60601-1 Edition 3.1 and Edition 3.2?

 

The main clauses affected in IEC 60601-1 Edition 3.2 are:

 

Clause 2 normative references
Clause 3 terminology and definitions
Clause 7 identification and marking
Clause 8 protection against electrical hazards
Clause 11 protection against excessive temperatures and other hazards
Clause 13 hazardous situations and fault conditions
Clause 14 programmable electrical medical systems (PEMS)

 

Importantly, the normative references of the standard have also been updated in Edition 3.2. The changes to referenced standards are shown in bold text below:

 

IEC 60065:2001+AMD1:2005+AMD2:2010 Audio, video and similar electronic apparatus
IEC 60068-2-2:2007 Environmental testing
IEC 60227-1:2007 Insulated cables
IEC 60245-1:2003+AMD1:2007 Rubber insulated cables – general requirements
IEC 60335-1:2010 Household and similar appliances
IEC 60417 Graphical symbols for use on equipment
IEC 60601-1-2:2014+AMD1:2020 Electromagnetic disturbances – requirements and tests
IEC 60601-1-3:2008+AMD1:2013 Radiation protection in diagnostic X-ray equipment
IEC 60601-1-6:2010+AMD1:2013+AMD2:2020 Usability
IEC 60601-1-8:2006+AMD1:2012+AMD2:2020 Alarm systems in medical electrical equipment
IEC 60664-1:2007 Insulation coordination
IEC 60730-1:2014 Automatic electrical controls for household and similar use
IEC 60747-5-5:2007 Semiconductor devices – optoelectronic devices - photocouplers
IEC 60825-1:2014 Safety of laser products

IEC 60065:2001+AMD1:2005+AMD2:2010 Audio, video and similar electronic apparatus IEC 60068-2-2:2007 Environmental testing
IEC 60227-1:2007 Insulated cables
IEC 60245-1:2003+AMD1:2007 Rubber insulated cables – general requirements
IEC 60335-1:2010 Household and similar appliances
IEC 60417 Graphical symbols for use on equipment
IEC 60601-1-2:2014+AMD1:2020 Electromagnetic disturbances – requirements and tests IEC 60601-1-3:2008+AMD1:2013 Radiation protection in diagnostic X-ray equipment
IEC 60601-1-6:2010+AMD1:2013+AMD2:2020 Usability
IEC 60601-1-8:2006+AMD1:2012+AMD2:2020 Alarm systems in medical electrical equipment
IEC 60664-1:2007 Insulation coordination
IEC 60730-1:2014 Automatic electrical controls for household and similar use
IEC 60747-5-5:2007 Semiconductor devices – optoelectronic devices - photocouplers
IEC 60825-1:2014 Safety of laser products
IEC 60851-3:2009 Winding wires – test methods mechanical properties
IEC 60851-5:2008 Winding wires – test methods electrical properties
IEC 60950-1:2005+AMD1:2009+AMD2:2013 Information technology equipment
IEC 61058-1:2000+AMD1:2001+AMD2:2007 Switches for appliances
IEC 62133 Secondary cells and batteries
IEC 62133-2 Secondary cells and batteries (Lithium systems)
IEC 62304:2006+AMD1:2015 Medical device software – software life cycle processes
IEC 62368-1:2018 Audio/ video, information, and communication technology equipment
ISO 7010:2019 Graphical symbols
ISO 11135-1:2007 Sterilization of health care products – Ethylene oxide
ISO 11137-1:2006 Sterilization of health care products – requirements for validation
ISO 13857:2008 Safety of machinery
ISO 14971:2019 Medical devices – application of risk management
ISO 15223-1:2016 Medical devices – symbols used with medical device labels
ISO 17665-1:2006 Sterilization of health care products – requirements for validation (moist heat)
ISO 80000-1:2009 Quantities and units

 

What do these changes mean in practice?

 

Due to the technological progress and resulting technical changes, the standards to ensure a safe and effective medical device needs to develop too (state of the art). To comply with IEC 60601-1 3.2 edition the latest editions of applicable process, particular, collateral, and component standards need to be considered by the medical device applicant.

 

Medical device manufacturers are advised to take advantage of the transition period to perform a gap analysis of their technical documentation (TD) against Edition 3.2 and update their documentation accordingly. Once potential gaps have been cleared, a new test report according to IEC 60601-1:2005+AMD1:2012+AMD2:2020 Edition 3.2 can be requested from an external ISO/IEC 17025 accredited testing laboratory. If the current IEC 60601-1 test report uses CB-Scheme as test scheme, it should be kept in mind that according to IEC Operational Document OD-2037 clause 3.1, a new Certification Body (CB) test certificate shall be issued with a new CB test certificate number. Thanks to the fact that now the TD will have been revised to comply with technical state of the art, a smooth certification process will be assured.

 

Let's focus on the changes to IEC 60601-1 clause 8 - protection against electrical hazards and clause 14 - programmable electrical medical systems. One noticeable change to clause 8 concerns the introduction of the requirement to measure the voltage of all accessible conductive parts of the Signal Input/ Signal Output (SIP/SOP) or power output connectors to earth for medical electrical equipment which is equipped with SIP/SOP connectors or separate power supply output connectors. Depending on whether the voltage is greater than 60Vdc or 42,4Vac - touch current measurement according to clause 8.7.3 will need to be conducted. For measuring the voltage of the SIP/SOP, please refer to the below-mentioned electrical schematic.

Figure 1 - Schematic Overview

 

Another noteworthy update of IEC 60601-1 Edition 3.2 affecting clause 8 is the addition of the normative reference to the standard IEC 60747-5-5:2007 Semiconductor devices – optoelectronic devices – photocouplers. Optocouplers which comply with IEC 60747-5-5:2007 or a later edition are considered equivalent to the requirements of 8.8.2 for distances through solid insulation and 8.9.3 for spaces filled by insulation compound. If your medical electrical device or system uses an optocoupler as a solid insulation forming a means of operator protection, the following verification measures apply and need to be conducted:

 

Air clearance at the outside of the opto-coupler
Creepage distance at the outside of the opto-coupler
Dielectric strength across the opto-coupler

 

Moreover, Clause 14 Programmable Electrical Medical Systems (PEMS) introduced a direct reference to IEC 62304:2006+AMD1:2015 Medical device software – software life cycle processes. Please keep in mind that the requirements in subclauses 14.2 to 14.12 shall apply to PEMS if the medical electrical equipment uses Programmable Electronics Subsystem (PESS) to provide functionality necessary for basic safety or essential performance or if the application of risk management as described in 4.2 shows that the failure of any PESS leads to an unacceptable risk. Medical device manufacturers are required to evaluate if clause 14 of IEC 60601-1 - and therefore specific clauses of IEC 62304 - are applicable.

 

How can Medidee support your company?

 

Our team of electrical safety specialists at Medidee assist you in identifying all areas requiring updates to meet the new requirements introduced by IEC 60601-1 Edition 3.2 through a detailed review of the technical documentation of your medical electrical device or system, as well as provide support in the implementation of applicable new IEC 60601-1 Edition 3.2 requirements. For instance, Medidee reviews and updates the list of critical components and insulation diagram, and process referenced standard-related changes incurred by the update of referenced standards ISO 14971:2019, IEC 62304:2006+AMD1:2015, and IEC 60601-1-6:2010+AMD1:2013+AMD2:2020/ IEC 62366-1:2015+AMD1:2020.

 

In addition, Medidee supports you in communicating with external accredited testing laboratories and notified bodies, to ensure a smooth certification process of the medical electrical equipment or system.

 

Contact Medidee today to discuss your needs and how Medidee supports you in addressing them: www.medidee.com/contacts

 

This article was written by Stefan Staltmayr.


Electromagnetic Compatibility EMC

[ARTICLE] Electromagnetic Compatibility: How changes to IEC 60601 Series trigger additional testing for your device (IEC 60601-1-2, Edition 4.1)

This article is the second one of a series about IEC 60601. It contains insightful information about amendment 1 of IEC 60601-1-2, following a similar structure as the first article.

 

The latest amendment 1 of IEC 60601-1-2 for Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (IEC 60601-1-2 Edition 4.1) was published on 2020-09-01 by the International Electrotechnical Commission (IEC). Edition 4.1 notably addresses issues raised by national committees and questions submitted to IEC/SC 62A with regard to previous version 4.0.

 

Since the 21st of December 2020, the United States Food & Drug Administration (FDA) has listed IEC 60601-1-2 4.1 Edition Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests as a recognized standard (FDA recognition number 19-36). IEC 60601-1-2 4.1 Edition will replace the current listed IEC 60601-1-2 4th Edition (FDA recognition number 19-8) by the 17th of December 2023. Until this date, FDA will accept declarations of conformity referring to IEC 60601-1-2 4th Edition, in support of the premarket submission.

 

To date, no announcement relative to an official transition period for the applicability of Edition 4.1 or to its harmonization under the Medical Device Directive (93/42/EEC) or Medical Device Regulation (EU 2017/745) has been issued in the official journal of the European Union.

 

In the absence of any official communication within the European Union on the matter, it is anticipated that manufacturers will be granted a transition period of 3 to 4 years after the date of publication before they will be expected to demonstrate compliance with the applicable new requirements introduced by the amended standard.

 

WHAT ARE THE MAIN DIFFERENCES BETWEEN CURRENT IEC 60601-1-2 EDITION 4.0 AND EDITION 4.1?

 

Clauses affected in IEC 60601-1-2 Edition 4.1 compared to 4.0 Edition are:

 

Clause 2 Normative references

Clause 3 Terms and definitions

Clause 4.3.3 Power input voltages and frequencies Table 1 – Power input voltages and frequencies during the tests

Clause 7.1.12 Permanently installed large ME equipment and large ME systems

Clause 7.3 Emissions requirements summary Table 2 – Emission limits per environment

Clause 8.1 Electromagnetic immunity requirements for ME equipment and ME systems - general

Clause 8.6 Permanently installed large ME equipment and large ME systems

Clause 8.9 Immunity test levels

Clause 8.11 Immunity to proximity magnetic fields in the frequency range 9kHz to 13,56 MHz

Figure 3 – Examples of locations within EM environments

Table 4 – Enclosure Port

Table 5 – Input a.c. power port (1 of 2 and 2 of 2)

Table 8 – SIP/SOP port

Table 9 – Test specifications for enclosure port immunity to RF wireless communications equipment

Table 10 – minimum test report contents (2 of 2)

Table 11 – Test specifications for enclosure port immunity to proximity magnetic fields

Table A.3 – Test specifications for enclosure port immunity to RF wireless communications equipment

Annex A.1 Safety and performance

Subclause 4.2 – Non-ME equipment used in an ME system

Subclause 4.3.3 – Power input voltages and frequencies

Subclause 5.2.2.1 a), Compliance with each emission and immunity standard

Subclause 7.1.12 – Permanently installed large ME equipment and Large ME systems

Subclause 8.6 – Permanently installed large ME equipment and large ME systems

Subclause 8.9 – Immunity test levels b) Environments

Subclause 8.9 – Immunity test levels c) Immunity test level determination

Subclause 8.10 – Immunity to proximity fields from RF wireless communications equipment

Subclause 8.11 – Immunity to proximity magnetic fields in the frequency range 9 kHz to 13,56 MHz

Annex F Guidance on the application of risk management with regard to electromagnetic disturbances in this collateral standard

Figure F.1 – Risk management flow in IEC 60601-1-2

Table G.1 Recommended minimum test plan contents (2 of 2)

 

Importantly, the normative references of the standard have also been updated in Edition 4.1. The changes to referenced standards are shown in bold text below:

 

IEC 60601-1:2005+AMD1:2012+AMD2:2020

IEC 60601-1-8:2006+AMD1:2012+AMD2:2020

IEC 60601-1-11:2015+AMD1:2020

IEC 60601-1-12:2014+AMD1:2020

IEC 61000-4-5:2014+AMD1:2017

IEC 61000-4-11:2004+AMD1:2017

IEC 61000-4-39:2017

CISPR 11:2015+AMD1:2016+AMD2:2019

CISPR 14-1:2016

CISPR 16-1-2:2014+AMD1:2017

CISPR 32:2015

ISO 14971:2019

 

WHAT DO THESE CHANGES MEAN IN PRACTICE?

 

Due to technological progress and resulting technical changes, the standards to ensure a safe and effective medical device need to develop too (state of the art). To comply with IEC 60601-1-2 4.1 edition, the latest editions of applicable process, particular, collateral, and component standards need to be considered by the medical device applicant.

 

Medical device manufacturers are advised to take advantage of the transition period to perform a gap analysis of their technical documentation (TD) against Edition 4.1 and update their documentation accordingly. Once potential gaps have been cleared, a new test report according to IEC 60601-1-2:2014+AMD1:2020 Edition 4.1 can be requested from an external ISO/IEC 17025 accredited testing laboratory. If the current IEC 60601-1-2 test report uses CB-Scheme as test scheme, it should be kept in mind that according to IEC Operational Document OD-2037 clause 3.1, a new Certification Body (CB) test certificate shall be issued with a new CB test certificate number. Thanks to the fact that now the TD will have been revised to comply with technical state of the art, a smooth certification process will be assured.

 

Let´s focus on the introduction to IEC 60601-1-2 clause 8.11 – immunity to proximity magnetic fields in the frequency range 9 kHz to 13,56 MHz.

 

Subclause 8.11 explains why this requirement has been added. Due to a wide variety of sources with radiated fields in professional healthcare facility environments and home healthcare environments, concerns about risks have been raised. Many medical electrical equipments contain electronic components and circuitry which might be sensitive to radiated magnetic fields (source: Cf. IEC 60601-1-2 Edition 4.1 Subclause 8.11). Figure A.3 – Steps for evaluation of immunity to proximity magnetic fields provides a great overview if testing in accordance with Table 11 of IEC 60601-1-2 4.1 Edition is applicable. IEC 61000-4-39 electromagnetic compatibility – part 4-39: Testing and measurement techniques – radiated fields in close proximity – immunity test, describe the test and measurement condition.

 

Another noteworthy update of IEC 60601-1-2 Edition 4.1 affects clause 4.3.3 power input voltage and frequencies. Table 1 of clause 4.3.3 specifies the power input voltages and frequencies during testing. For instance, conducted disturbances (conducted emissions) according to CISPR11:2015+AMD1:2016+AMD2:2019 specifies the power input voltage for minimum and maximum rated voltage, if the difference between the maximum and the minimum rated input voltage is greater than 25% of the highest rated input voltage. Meaning, if your medical electrical equipment has a wide range input voltage supply of 100Vac – 240Vac, the difference of maximum and minimum rated input voltage is 140Vac, which is greater than 25% of highest rated input voltage (240Vac*25% = 60Vac), therefore the test needs to be conducted at minimum and maximum rated input voltage.

 

Previous IEC 60601-1-2 Edition 4.0 specified this test according to CISPR11 at any one voltage.

 

How can Medidee support your company?

 

Medidee has a dedicated team of electrical safety specialists who assist you in identifying all areas requiring updates to meet the new requirements introduced by IEC 60601-1-2 Edition 4.1, through a detailed review of the technical documentation of your medical electrical device or system, as well as provide support in the implementation of applicable new IEC 60601-1-2 Edition 4.1 requirements and sub-standards like CISPR 11 or IEC 61000-4-39. For instance, Medidee reviews and updates the technical documentation according to the updated standards to comply with IEC 60601-1-2 Edition 4.1. Furthermore, Medidee updates the test plan which is required as input for external test labs.

 

In addition, Medidee supports you in communicating with external accredited testing laboratories and notified bodies, to ensure a smooth certification process of your medical electrical equipment or system.

 

Contact Medidee today to discuss your needs and how Medidee supports you in addressing them: www.medidee.com/contacts

 

This article was written by Stefan Staltmayr.


Webinar - MDR Technical Documentation

[WEBINAR] How to build compliant Technical Documentation (TD) under MDR?

HOW TO BUILD COMPLIANT TECHNICAL DOCUMENTATION (TD) UNDER MDR?

 

To expedite the Technical Documentation review process by the Notified Body and avoid extra costs and delays (which potentially could make your company miss the May 2024 deadline), your technical documentation submission needs to be right the first time!

 

Our experts Dr. Lydie Moreau and Philippe Etter tell you all about:

  • What are the additional requirements of MDR compared to previous directives
  • What is the structure your TD should comply to
  • How to make sure you have a clear traceability thread within your TD to demonstrate compliance to all GSPRs

 

WATCH THE WEBINAR

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Webinar - EU or US approval - Medidee

[WEBINAR] EU or US approval?

What is the best starting point for innovative Medical Devices & IVD companies?
 
With the deployment of MDR and IVDR, there is significant pressure to update the compliance documentation of medical devices, within a short amount of time. The notified bodies are also facing increasing workload due to a large number of conformity assessments.
 
Meanwhile, some companies identify that some products may be easier to bring on the US market during this burdensome EU phase.
 
This webinar covers both sides of this situation:
 

· What can be done to get existing devices approved under the new EU regulations
· How does the FDA pre-submission meetings help in the approval process?
· What is the best starting point for innovative companies: EU or US approval?

 
In this on-demand webinar, our experts Philippe Etter and Dr Milind Raje will guide you through the changing trends in EU and FDA approvals for medical devices and IVDs:
 

· MDR current status (including IVDR touch)
· The latest guidance from Notified Bodies
· Dealing with Notified Bodies
· Why are innovative companies trending towards US?
· Status of availability of FDA
· General Regulatory trends

 




MDR & IVDR Compliance (US companies)

[WEBINAR] MDR / IVDR compliance for US companies

With the deployment of MDR and IVDR, there is significant pressure on the industry, with short timelines and a clear burden on Notified Bodies.
 
US medical device and IVD companies with established products have limited choice besides upgrading documentation because EU remains a dense market with 750 million inhabitants and a large hospital every other 20 miles.
 
For innovative companies, the question remains complex because the timelines for starting a clinical trial on complex devices remain shorter in the EU, whereas simple devices, such as Digital Health solutions, are clearly easier to develop in the USA.
 
This webinar covers both sides of this situation:
 

· What can be done to get existing devices approved under the new EU regulations
· What are tactics for innovative companies

 
In this on-demand webinar, our experts from our office of Philadelphia, Tamara Lewis, Paige Sutton-Smith, and Philippe Etter, will guide you through the changing trends in EU for medical devices and IVDs:
 

· MDR current status (including IVDR touch)
· Latest guidances from Notified Bodies
· Planning of conformity assessments for MDR / IVDR transition
· Dealing with Notified Bodies, where to go
· EC-REP, UK-REP, CH-REP
· Clinical tactics in the EU

 



MDR IVDR Compliance Webinar - Australian companies

[WEBINAR] MDR / IVDR compliance for Australian companies

With the deployment of MDR and IVDR, there is significant pressure on the industry, with short timelines and a clear burden on Notified Bodies.
 
Australian medical device and IVD companies with established products have limited choice besides upgrading documentation because EU remains a dense market with 750 million inhabitants and a large hospital every other 20 miles.
 
For innovative companies, the question remains complex because the timelines for starting a clinical trial on complex devices remain shorter in the EU, whereas simple devices, such as Digital Health solutions, are clearly easier to develop in the USA.
 
This webinar covers both sides of these situations:
 

· What can be done to get existing devices approved under the new EU regulations
· What are tactics for innovative companies

 
In this on-demand webinar, our experts Philippe Etter and Dr Milind Raje will guide you through the changing trends in EU for medical devices and IVDs:
 

· MDR current status (including IVDR touch)
· Latest guidances from Notified Bodies
· Planning of conformity assessments for MDR / IVDR transition
· Dealing with Notified Bodies, where to go
· EC-REP, UK-REP, CH-REP
· Clinical tactics in the EU