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 manage the EU MDR transition process?
Navigating the EU MDD to MDR Transition
Europe’s Medical Devices Regulation 2017/745 (MDR) took effect in May 2021. For companies marketing their devices in the European Union, maintaining CE Mark certification means MDR compliance regardless of challenges such as Notified Body staff shortages and work backlogs.
Emergo can help with your European MDD to MDR transition. Emergo’s most senior regulatory consultants can identify the best EU MDR compliance strategy for your company based on your product range, certification cycle, markets you serve, and your Notified Body.
Changes in CE Marking compliance for medical device manufacturers with MDR 2017/745
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 is 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 on Europe's medical device regulation - MDR 2017/745.
EU MDD to MDR gap assessment: transition plan and checklist
Transitioning to the MDR might seem overwhelming, and many companies don’t know where to start. Your first step should be 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 recommended next step is to examine your current clinical data and Clinical Evaluation Report (CER) for medical devices 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.
CE MDR Gap Analysis with Emergo by UL
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 Devices Regulation. 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)
- 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.
MDD to MDR 2017/745 transition FAQs
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.
We just renewed our MDD certificate. When should we transition to the MDR?
MDD certificates issued prior to final implementation of the MDR in 2021 have a maximum validity of five years. However, all MDD certifications will automatically expire four years after the MDR's May 2021 date of application. 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 CE Mark 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.