The long awaited proposed Regulations for Medical Devices (and active implantable medical devices) and IVDs were released by the EU Commission. A new free white paper from the Emergo Group, Austin, TX, which provides regulatory consulting, explains several detailed items in the proposed legislation.
While the European medical device regulatory system remains largely intact, more details have been added, as well as new mechanisms to bolster weaknesses.
Among the changes are: Greater emphasis is placed on encouraging member state cooperation, interaction among the entities, and the use of the European database and UDI.
Much of the European guidance is now codified, making them mandatory.
Manufacturers (and Authorized Representatives) must have a Qualified Person.
The definitions section is significantly expanded. Economic operators are defined, and responsibilities assigned, which means importers and distributors are formally recognized as important elements in the supply chain as well.
Available routes to conformity assessment are consolidated.
For more information, download the white paper at the link below.
