What is the Medical Device Regulation (MDR)?
The Medical Device Regulation (MDR) is an EU regulation that has governed the requirements for placing medical devices on the market and monitoring them in the European Union since May 2021. It replaces the previous Medical Device Directive (MDD) and sets stricter requirements for the safety, proof of performance, traceability and clinical evaluation of medical devices. The aim of the MDR is to improve the safety, quality and traceability of medical devices in the EU and to impose stricter requirements on manufacturers, distributors and importers. All manufacturers, importers and distributors who offer medical devices such as implants, surgical instruments or software in the EU are affected.
Contents of the MDR
The MDR defines clear requirements for the development, manufacture and monitoring of medical devices. It requires comprehensive technical documentation, end-to-end risk management, clinical evaluations and regular performance reviews. Key elements include complete traceability, stricter market surveillance, clear product labelling via UDI codes and clear specifications for quality management systems. The requirements apply across the entire product life cycle - from development and production through to post-market traceability.
Application of the MDR
The MDR affects all companies that develop, manufacture, package, sterilise, distribute or supply quality-relevant components for medical devices. This includes, for example, manufacturers of implants, instruments, diagnostic devices or components such as Seals, membranes or Enclosures. Suppliers must prove that their materials and processes comply with the stricter regulatory requirements.