Authorized Representatives for Medical Devices
Whether a medical device requires a Notified Body (in the case of Class I sterile/measuring/ resusable or IIa, IIb, III) in order to obtain the CE Marking or is permitted to self-declare (Class I non-sterile, non-measuring), non-EU based manufacturers are legally obligated to appoint an Authorized Representative in order for their products to legally circulate within the EU Market.
Under the Medical Device Regulation, this Authorized Representative must be permanently and continuously available, qualified and possess the necessary expertise of the regulatory requirements for medical devices in the EU. More specifically, your Authorized Representative should have specifically identified a Person Responsible for Regulatory Compliance (PRRC) within their organization. A distributor, importer or EU Address without a qualified professional will no longer do.
Formal qualification criteria for E.A.R.'s PRRC - MDR Article 15 (6):
- University degree (documented by Diploma/Certificate) in law, medicine, pharmacy, engineering or another relevant discipline + at least one year of professional experience in regulatory affairs or in QMS relating to medical devices;
- four years of professional experience in regulatory affairs / in quality management systems relating to medical devices (…);
- The Regulation: MDR 2017/745
- Technical File
- Notified Bodies
- Custom Made Devices
- Clinical Evaluation & Clinical Investigation
- Systems & Procedure Packs
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