News about GMP/cGMP

03.08.2018

New MDR: Are deadlines in danger?

The MedTech Europe industry group calls on the European institutions to offer solutions to meet the deadlines for the new MDR and IVDR. Both regulations will apply from May 2020 and May 2022 respectively.

 

Medical device manufacturers are investing in compliance with the new regulations for

  • MDR (Medical Device Regulation) and
  • IVDR (In Vitro Diagnostic Medical Devices Regulations)

They will be ready to submit files to maintain patient and health care systems across Europe with over 500 000 medical technologies.

The slow progress in building the critical infrastructure could jeopardise the industry's ability to keep products on the market beyond the deadlines (26 May 2020 and 2022).

The products will no longer be approved on the market, if there is not enough time between the introduction of the system and the (re)certification of the products. As a result, they will no longer be available to patients and healthcare systems.

MedTech Europe calls on the European institutions to discuss urgent solutions to ensure that the systems are operational in a timely manner.


Source:

MedTec Europe

 



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