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Dear, First I want to thank you to permit to give our feedback. Below some questions/ comments : - Harmonization for qualification of product reviewer and recognition at European Level RDM 2017/745 Annex VII §3.2.5 Criteria for qualification of product reviewer is not sufficiently detailed in RDM 2017/745 and subject to the interpretation and not harmonization between NB regarding qualification.

EuromContact agrees with the initial postulate of the proposal : many devices which may be placed on the market in accordance with the initial MDR transitional provisions are not going to be certified in accordance with that Regulation before the end of the transition period, which leads to a major risk of shortages of medical devices in the EU.

I fully share the objective of this revision. It is indeed essential to adapt the regulatory framework in order to enable companies, particularly SMEs, to cope with requirements that can sometimes be disproportionate, with unpredictable timelines and an administrative burden that has become difficult to sustain.

EuromContact, the European association representing manufacturers of contact lenses and lens care products, welcomes this consultation and agrees with the assessment that MDR implementation has shown inconsistent and divergent interpretations of certain requirements set out in MDR Annex VII, especially as regards the timelines for completing conformity assessment activities and re-certification.