EU: Proposal for Simplification of Medical Device Rules
The European Commission has proposed targeted reforms to simplify the Medical Device Regulation (Regulation (EU) 2017/745, MDR) and the In Vitro Diagnostic Regulation (Regulation (EU) 2017/746, IVDR) and to address structural implementation challenges. The key points are:
- Reduced administrative burden: Simplified requirements for manufacturers, including more flexible rules for the Person Responsible for Regulatory Compliance (PRRC) – particularly for small and medium-sized enterprises – fewer Periodic Safety Update Reports, simplified reporting obligations, and reduced requirements for the Summary of Safety and (Clinical) Performance.
- More proportionate regulation: Introduction of a new concept for well-established technologies, more flexible use of clinical data, and adjusted classification rules that better reflect the actual risk of devices.
- Faster and more predictable certification: Removal of the maximum five-year validity of certificates, set timelines for notified bodies, and greater flexibility through Predetermined Change Control Plans.
- Support for innovation and availability: Measures to support breakthrough medical technologies and to help prevent device shortages.
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