The new EU Regulation on Medical Devices (MDR) will apply fully from 26 May 2020 and the Regulation on In Vitro Diagnostic Medical Devices (IVDR) from 26 May 2022.
As a legal manufacturer, you must meet new obligations set out in the Regulation and will need to ensure:
- – The device has the correct classification (Annex VIII)
- – General safety and performance requirements (GSPRs) are met (Annex I)
- – Increased requirements for clinical evidence are met (Annex XIV)
- – Have a person responsible for regulatory compliance (PRRC) in place (Article 15)
- – Economic operators in the supply chain are compliant
- – Vigilance reporting timescales are met and that an annual periodic safety update report (PSUR) is created (Chapter VII, Section 1 and 2)
- – Additional obligations that must also be met (see Article 10).
The European Commission has details and guidance documents on the new Regulations EC Guidance with updates and new information added regularly. Currently there are documents on the European Databank on Medical Devices (EUDAMED) , Unique Device Identification (UDI) and Notified Bodies (NBs), with recent guidance issued on Implant Card (IC) and the application of Article 18 and ‘person responsible for regulatory compliance’ (PRRC) and the application of Article 15.