NEW MEDICAL DEVICE REGULATION(MDR): TOP 5 CHALLENGES

Within the medical devices industry, professionals have long been exercising acquiescence with regards to the new European Medical Device Regulation (MDR). At last, after a very lengthy process the MDR was finalized and it was duly published in the Official Journal of the European Union on 5th May, 2017.

           

With the passing of the new MDR, the previous regulations viz., the Active Implantable Medical Device Directive (90/385/EEC) as well as the Medical Device Directive has been totally replaced. The primary objective of the Revision of Medical Device Regulation is to ensure a regulatory framework that is sustainable, forceful, foreseeable and clear which is essential for ensuring that the level of safety is
extremely high within the healthcare sector and at the same time fosters innovation

Guidance to Medical Device Regulations in Europe

To highlight the key modifications that have been effected by the new MDR and to resolve these issues, the top five hurdles that device manufacturers will need to take care once the transition period of the new MDR is over, has been outlined as under:

Top 5 Challenges are:

1) Reclassification
2) Market Access of Legacy Products
3) Reprocessing Single Use Device
4) Technical Documentation
5) Clinical Evaluation

To know how to handle and resolve this issues click here

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Dr.Nancy,

Editor-in-chief,

Medical Writing Experts.

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