... for the extended transition period for the Medical Device Regulation (EU) 2017/745
Manufacturers who have yet to submit an application for MDR certification to a notified body before 26 May 2024, will no longer be allowed to put batches of their medical devices certified in accordance with the Directives 93/42/EEC and 30/385/EEC on the market.
But … acknowledge the moment and seize the opportunity!
There may be various reasons why manufacturers have neither submitted an MDR certification nor completed a contract with a notified body.
The assumption that it is too late is debatable!
The timely application, in conjunction with a certification contract, enables the sale of medical devices, including those already on the market until 31 December 2028.
Here is the answer: 0251- 60 93 53 12