New legislation on Medical Device
By William Chin, PhD, Scientific Coordinator, EUCRAF
In September 2012, the European Commission published a proposal for a new regulation on Medical Devices, which was amended by the Parliament in October 2013. The new Latvian Presidency of the Council of the European Union (1 January – 30 June 2015) has pledge to seek a Council mandate in order to reach an agreement with the European Parliament on the proposal for medical devices and in vitro medical devices. This priority is set to aim for a robust, transparent and sustainable regulatory framework to support innovation and the competitiveness of the medical device industry and to allow rapid and cost-efficient market access for innovative medical devices is necessary for the benefit of patients and healthcare professionals alike. Here are some of the significant changes expected in the new Medical Device Regulation:
- The European Commission will be able to review recommendations for CE Marking prior to approval.
- The European Commission’s ability to create common technical specifications (CTS) will be expanded to all devices.
- Only newly created Special Notified Bodies will be able to issue CE Certificates for high-risk devices such as implants.
- Notified Bodies will be audited for compliance with the new regulations jointly by Competent Authorities (i.e., the regulatory body for each member state).
- Manufacturers will be subject to unannounced audits by Notified Bodies.
- Formatting of declarations of conformity and technical files will be revised.
1. What to Expect from New EU Medical Device Regulations, Jamie Hartford, 5 May 2014, MDDI
2. New regulations on medical devices in Europe: what to expect? Expert Rev Med Devices. 2014 Jul;11(4):351-9
3. Latvian Presidency of the Council of the EU website