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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.

Ask us for detailed information about EU MDR Gap Assessment services.

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Common MDD to MDR 2017/745 transition questions

Our MDD CE Marking certificate expires soon. Should we re-certify under the MDR?
This is a complicated issue that depends on your Notified Body’s current designation status, the actual date of your certificate expiration, the completeness of your clinical data, and your internal resources. We address this topic in detail in this white paper on MDR transition timelines.

NOTE: The big unknown is the order in which Notified Bodies will be designated for the MDR and when this will start. Until there is clarity on this subject, the above question is very difficult to answer with certainty.

We just renewed our MDD certificate. When should we transition to the MDR?
MDD certificates issued prior to final implementation of the MDR (around Q2 2020) have a maximum validity of five years. However, all MDD certifications will automatically expire four years after the new Regulation comes into effect. You can wait until 2023 (for MDD Annex IV certificates) or 2024 to renew under the MDR, but this comes with uncertainties that could leave you with an expired certificate.

Our Notified Body (NB) indicated they are exiting the medical device business. How do we find a new one?
In addition to increased workloads, the number of Notified Bodies operating in Europe is getting smaller and those that remain have to carefully reconsider their scope. Emergo can assist with Notified Body evaluation if you find yourself without an NB during the transition phase. Listen to this free webinar and download our white paper about Notified Body selection to learn more about how to find a new certification partner in Europe.

We have a family of Class I, self-certified devices that will fall in Class IIa under the MDR. When do we have to transition to the MDR?
From the day of application of the MDR, these Class I devices can no longer be placed on the market. (Stocks already placed on the market can be sold out.) As there is no ‘grace period’ for your devices, we recommend going for timely transition as there may be bottlenecks in Notified Body capacity around 2020.

We are developing a new device. Is it still possible to certify under the MDD?
New MDD certificates can be issued until the date of application of the MDR After that, all new certificates will be issued under the MDR. The certification type you choose will mainly depend on when you want to introduce your device on the market. If you are early, there may not be a designated Notified Body available. In that case, you have to choose MDD certification. If you are very late, your device may enter the market after Q2 of 2020 when only MDR certificates are issued. If you are somewhere in between, you may have a choice between either strategy. This also depends on what your Notified Body will accept for your device.