TÜV Rheinland (DE) has received designation as a Notified Body for the purposes of the In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746.
This brings the total number of IVDR Notified Bodies to five: DEKRA; TÜV SÜD; BSI (Netherlands) and BSI (UK). Although, BSI (UK) will cease to be recognised by the EU in 2021 once the Brexit transition period expires.
The IVDR is a genuinely revolutionary change in the regulation of in vitro diagnostics (IVDs) in Europe. No existing IVDs will benefit from grandfathering and there is no real transitional period once the legislation takes effect. Further, 85% of IVDs currently on the market on a self-certified basis will need conformity assessment by a Notified Body. This doesn't take account of the large number of new IVDs that are being developed and that must also undergo a conformity assessment.
The IVDR takes effect in May 2022, leaving manufacturers with a terrifyingly short period of 18 months to move to compliance. Better late than never, the European Commission is taking baby steps to increase the number of Notified Bodies to meet the tsunami of demand. This will do very little to alleviate the concerns of stakeholders or quell the calls from industry bodies such as MedTech to delay the implementation deadline for the IVDR to take effect.
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