Common questions regarding EU CE Marking for in-vitro diagnostic (IVD) medical devices
Do we need an Authorized Representative (EC REP) if we are marketing a self-certified IVD?
Yes. You must select an EC REP if you do not have a place of business in Europe, regardless of the category or classification of your IVD. Read more about Emergo Authorized Representation services.
Are Notified Body audits required for all types of IVDs?
Unless you are marketing a self-certified IVD device, you will need the intervention of a Notified Body and a Notified Body CE Certificate. In fact, most IVD manufacturers will need to engage Notified Bodies as part of the conformity assessment procedures under Europe's new In Vitro Diagnostic Regulation (IVDR 2017/746).
How will the IVDR affect current CE Marking certification for our product?
The IVDR will come into force in 2022. CE Marking certificates issued before final implementation of the IVDR will remain valid for a maximum of two years following final implementation of the new regulations. If your IVD is self-certified under the IVDD, and Class A sterile, B, C or D according to the IVDR, you must possess a Notified body issued CE marking certificate on 26 May 2022 in order to continue market the IVD in the EU.
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 MDR 2017/745 Gap Assessment and CE Transition Strategy
- European Union Medical Device Classification
- In Vitro Diagnostics Regulation (EU IVDR) On-Site Training
- 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