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Member company offers regulatory partnership to other BIVDA members

By December 17, 2021No Comments

Transition into compliance with IVDR necessitates a considerable investment by manufacturers in their Quality Management Systems (QMS) and subsequent certification by Notified Bodies.

We are aware that for SMEs in particular this can represent a considerable, sometimes disproportionate, burden. However, one of our SME members has recently successfully completed its Notified Body audit in line with IVDR requirements and has an established QMS that is now capable of supporting a larger product portfolio.

Given that many businesses are struggling to progress to QMS certification due to the very limited Notified Body capacity, this member company is open to discussions with other members who may be interested in working together to leverage its IVDR ready and audited QMS for other products, (in particular those which already have robust technical documentation, but are lacking a certified QMS).

Whilst it is expected that the deadline for the compliance with IVDR for existing on-market products will be extended, this may be of particular interest to businesses that intend to launch new, or significantly changed products post-May 2022.

Any expression of interest in confidence to Doris-Ann please.

Ben Kemp