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.
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. 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 are developing a new device. Is it still possible to certify under the MDD?
New MDD certificates could be issued up until the May 2021 date of application for the MDR. Now, all new CE certificates will be issued under the MDR.
Additional services for Europe:
- CE Mark Certification for Medical Devices
- Clinical Evaluation Reports (CER) for Medical Devices in Europe
- EU IVDR Gap Assessment and CE Transition for IVD Companies
- EU MDR compliance consulting for cosmetic and aesthetic products
- EU Medical Device Vigilance Reporting in Europe
- EU Post-Market Clinical Follow-up Studies (PMCF) for Medical Devices
- European Authorized Representative for Clinical Trials
- European Authorized Representative for Medical Device Companies
- European Union Medical Device Classification
- In Vitro Diagnostics Regulation (EU IVDR) On-Site Training
- IVD Certification and Registration to Obtain CE Marking in Europe
- Medical Device and IVD Emergency Use Routes in Europe
- Medical Device Technical File and Design Dossier for EU CE Marking
- Switzerland Representative for Medical Device Companies
- UKRP and Brexit consulting for medical device companies