Saturday, 16 January 2016

New EU medical device regulations


In a statement the Council of Ministers confirmed that a mandate has been given for its Luxembourg presidency to open 'trilogue' talks with the European Parliament and European Commission on the planned new Medical Devices Regulation and In-Vitro Medical Devices Regulation. The aim is to have something in place by early 2016.

The proposals extend to sticking plasters, pregnancy tests and contact lenses, as well as x-ray machines, pacemakers, breast implants, hip replacements and HIV blood tests, and so forth.

The aim of the revisions is to ensure:
  • A consistently high level of health and safety protection for EU citizens using these products;
  • The free and fair trade of the products throughout the EU;
  • That EU legislation is adapted to the significant technological and scientific progress in this sector over the last 20 years.
  • Revisions included the extending of the scope for legislation; better supervision of independent assessment bodies; clear rights for manufacturers/distributors; and stronger requirements for medical evidence.



 Posted by Dr. Tim Sandle