On 25 May 2016 the European Parliament and the European Council jointly announced that an agreement has been reached about the long-awaited Regulations for Medical Devices and In-Vitro Diagnostics. The First Reading Drafts will be published mid-June and the Regulations is expected to be adopted by the of 2016. Manufacturers whose devices are CE Marked for sale in the European Union will have a three-year transition period for medical devices and a five-year transition for IVDs.
Manufacturers should expect the following high-level changes:
- The requirement for a higher level of clinical evidence;
- Certain high risk devices, such as implants, may undergo an additional check by experts before they are placed on the market;
- All economic operators (Manufacturers, Authorised Representatives, Importers and Distributors) will have to be involved in ensuring compliance and can be held responsible for any non-compliance;
- Mandatory Unique Device Identification (UDI) is introduced with the intention to facilitate the traceability of devices. A central database will be set up to create an improved system for all relevant information.
Contact Regulis to understand how the new Regulation will impact you as a medical device manufacture and how to get the transition process started.