[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.