New expectations set by MDR and Notified Bodies, combined with tight timelines, require companies to be more proactive than ever

MDR Timelines and Requirements

Since the entry into force of the Medical Device Regulation (MDR – Regulation EU 2017/745) on May 26th, 2017, manufacturers are working hard to gather and establish evidence of compliance for their legacy devices.  

All devices on the market will have to undergo a new and complete Conformity Assessment under the new ruling, latest by May 2024. Most manufacturers developing new devices already shifted towards the new regulation. But for those who have legacy products, an in-depth understanding of the transition provisions is key to determining the strategic options and to setting up a roadmap tailored to specific devices. 

Key Challenges for a Successful Transition to MDR

Verification & Validation (V&V)

With the introduction of the concept of state-of-the-art and the ongoing effort towards harmonization of standards, companies may be thrown into confusion as to which sources to use to demonstrate compliance. Building a strong (statistical) justification of sample size can also be a daunting task.

Clinical Evaluation

Evidencing Clinical Benefit requires defining and demonstrating Safety and Performance criteria for each indication. New criteria for equivalence call for more clinical data through Post Market Surveillance. Some companies also wonder if they can benefit from Well-Established Technology status.

Risk Management

A new Conformity Assessment often crystallises the insufficient homogeneity between the various risk analysis, product testing and process mitigations such as incoming, in process and final QC. Moreover, the process validation activities are quite systematically disconnected from actual risks.  

White Paper: Technical Documentation and Medical Device Regulation

Get the Full Guide for Manufacturers to Ensure Technical Documentation Complies with EU Medical Device Regulation 2017/745.

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How Medidee Supports your MDR Transition Process

An effective MDR transfer strategy often starts by conducting an assessment of the existing Technical Documentation, whatever its status of readiness is. With our expertise and resources, we make the process easy for you by:

Assessing your Technical Documentation against MDR Requirements but also at the light of our recent experience with Notified Bodies

Assisting with subsequent updates required through training, coaching, execution or any combination of those

Consolidating your Clinical Evaluation file, from updating CEP and CER to defining adequate PMS and PMCF plans

With increased requirements under the MDR, and a decreased number of Notified Bodies, obtaining a certification takes longer and longer. In this webinar, Medidee will share with you how to get your Technical Documentation submission right the first time, so you can avoid extra costs and delays (which potentially could make your company miss the May 2024 deadline).

Watch the Webinar

An Efficient, Business-Oriented Approach

With the significant increase in requirements combined with tight timelines from Notified Bodies, you only get one chance to be successful with your Conformity Assessment process. Therefore, to ensure business continuity, being “right the first time” is crucial.

 

Medidee focuses on increasing the coherence and the dependability of all the dimensions considered for your submission, with a business-oriented view. 

By working proactively with us, you will ensure that your Technical Documentation integrates the latest requirements and expectations, for a well-managed transition to MDR. 

Contact Medidee to discuss your needs