MDR - Chapter II - article 8

Original text

Expert opinion

Common specifications

1. Without prejudice to Article 1(2) and 17(5) and the deadline laid down in those provisions, where no harmonised standards exist or where relevant harmonised standards are not sufficient, or where there is a need to address public health concerns, the Commission, after having consulted the MDCG, may, by means of implementing acts, adopt common specifications (CS) in respect of the general safety and performance requirements set out in Annex I, the technical documentation set out in Annexes II and III, the clinical evaluation and post-market clinical follow-up set out in Annex XIV or the requirements regarding clinical investigation set out in Annex XV. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).

Common specifications (CS)

Common specifications are understood to fill a gap in harmonised standards or insufficiently covering standards to meet the basic requirement of the general safety and performance.

These CS most probably are to be expected in topics such as technical documentation and other not-standardized topics.

2. Devices that are in conformity with the CS referred to in paragraph 1 shall be presumed to be in conformity with the requirements of this Regulation covered by those CS or the relevant parts of those CS.

Compliance is given when the CS are followed either partially or at whole. Important here is to justify that the CS is relevant and followed.

3. Manufacturers shall comply with the CS referred to in paragraph 1 unless they can duly justify that they have adopted solutions that ensure a level of safety and performance that is at least equivalent thereto.

4. Notwithstanding paragraph 3, manufacturers of products listed in Annex XVI shall comply with the relevant CS for those products

Please be informed that the products listed in Annex XVI must comply with the relevant CS and the MDCG leaves the doors open to which and when to implement a new CS.

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