EU MDR 2017/745 Gap Assessment and CE Transition Strategy for Medical Device Manufacturers

ANSWERED ON THIS PAGE:

  • What are the deadlines for MDD to MDR 2017/745 compliance?
  • What are the biggest changes in the EU Medical Devices Regulation (MDR)?
  • How should my company begin the EU MDR transition process?

Europe’s new Medical Devices Regulation 2017/745 (MDR) is finally here and takes effect in mid-2020. That seems like plenty of time, but smart companies should start planning their CE transition strategy right away. With manufacturers all over the world transitioning to the MDR and ISO 13485:2016 in the next few years, Notified Body staff shortages and work backlogs are likely to cause delays.

Emergo can help with your European MDD to MDR transition. Emergo’s most senior regulatory consultants can identify the best transition strategy for your company based on your product range, certification cycle, markets you serve, and your Notified Body.

Biggest changes in MDR 2017/745 for device manufacturers

Compared to the MDD, MDR 2017/745 introduces a life-cycle approach to ongoing CE Marking compliance. Conformity assessment procedures are more complex, and equivalence will be more rigorously interpreted.

Your clinical data and Clinical Evaluation Report (CER) will face heavy scrutiny and require recurring updates. You must also fulfill increased post-market surveillance requirements, perform more Post-Market Clinical Follow-up (PMCF) studies, and deliver Period Safety Update Reports (Class IIa devices and above). Read more about the MDR changes in our white paper.

EU MDD to MDR 2017/745 transition strategy and plan

Transitioning to the MDR might seem overwhelming and many companies don’t know where to start. The first step is to assess your current level of compliance. A thorough gap analysis will generate a task list for updating your procedures and documentation. Emergo can assist with this.

A smart next step is to examine your current clinical data and Clinical Evaluation Report to make sure you comply with MEDDEV 2.7/1 rev 4. Notified Bodies are already requiring a higher level of overall quality for clinical evidence and complying with clinical data requirements will be a major hurdle for many companies. Get started as soon as possible to avoid unforeseen challenges as hard deadlines approach.

Emergo can help you get started with a thorough CE MDR gap analysis

Emergo can perform a systematic, independent gap analysis of your CE technical documentation, procedures, and processes to help you understand what steps you must take to meet requirements of the Medical Device Regulations. Our in-depth MDR gap analysis is done by Emergo’s most senior consultants and includes a review of your:

  • CE Marking Technical File or Design Dossier
  • Current device class and product families
  • Risk management file review
  • Clinical Evaluation Report(s)
  • Labeling
  • Post-market surveillance (process, plan, effectiveness, PMCF, and results)
  • Economic Operators Agreements Review, including your European Authorized Representative (EC REP) agreement
  • Supply and distribution chain management procedures
  • Relations with your current Notified Body
  • Product life cycle plan

We will deliver a comprehensive report detailing deficiencies, with recommendations on how to fix them and the order in which you should address them.

Emergo has helped medical device manufacturers comply with European regulations since 1997. We have four offices in Europe and act as the official EC REP for 1,000+ medical device companies, so we are uniquely qualified to help you make a smooth transition to the new Medical Devices Regulation.

Don’t put it off. Contact us today to learn how we can help you with transition to new EU Medical Device Regulation.

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