When the National Standards Authority of Ireland got the nod from the European Commission last month to carry out certifications of in-vitro medical devices under a new regulatory framework, it joined a relatively small network of inspectors around Europe that are cleared to do so. That relatively small number is at the heart of a lingering issue for Europe’s medical device sector and patients’ access to vital devices for care. The EU’s Medical Device Regulation (MDR) and the In-Vitro Diagnostics Regulation (IVDR), two sister regulations, were passed at the end of the 2010s and have caused great concern for the…

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