A long awaited proposal for revisions to the EU Medical Device Directives was published on 26 September.
The revisions aim to address a range of issues:
- Existing EU rules have not kept pace with the enormous technological and scientific progress in the past 20 years.
- EU countries interpret and implement the current rules in different ways.
- It is not always possible to trace medical devices back to their supplier. New rules on traceability are needed.
- Patients, healthcare professionals and other interested parties do not have access to essential information on how medical devices have been assessed, and what clinical evidence there is to show they are safe and effective.
The plan is to adopt changes to address these issues in 2014, with implementation between 2015 and 2019, Expect to see a tightening up on requirements for supporting clinical evidence, increased powers of inspection for assessment bodies (including unannounced inspections). Medical device risk classification categories are expected to increase to 4, instead of the current 3.
Read the detail of the revision proposals on the European Commission Public Health website here