The new Medical Device Regulations, whose final drafts were published by the Council of the European Union last week, will result in an additional layer of review of technical documentation for certain manufacturers of medical devices. If you manufacture implantable class III devices (e.g. pacemakers) or class IIb active devices intended to administer and/or remove a medicinal product (e.g. drug delivery systems), you will need to be prepared for two additional layers of review of your technical documentation.
This article contains a general summary of developments and is not a complete or definitive statement of the law. Specific legal advice should be obtained where appropriate.