New European Commission introducing presumption of conformity with EU ISO standards in new areas

The European Commission has published a new Implementing Decision concerning EU ISO harmonised standards for:

• biological evaluation of medical devices;

• symbols to be used with information to be supplied by the manufacturer;

• medical electrical equipment;

• transfusion equipment for medical use;

• ophthalmic optics;

• non-active surgical implants;

• washer-disinfectors;

• prosthetics; and

• sharps injury protection.

‍Some of the additions introduce new standards while others update existing standards.

Compliance with the EU ISO standards provided in the Implementing Decision is not obligatory. However, compliance with the standards creates a presumption of conformity with the related obligations provided in the MDR.

The updated versions of EU ISO 10993 biological evaluation of medical devices will replace the existing standards from 15 December 2027.

‍The updated version of EU ISO 15223 changes the symbol for authorised representatives on medical device labelling. As a result, the transition period for this standard continues until 17 June 2031. This change is accompanied by a revision to the MDCG 2021-5 Guidance. The Guidance underlines that the change is “purely editorial in nature”. Nevertheless, it will become obligatory from 17 June 2031.

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