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As a French SME operating in the medical device sector, we welcome the European Commissions initiative to simplify and streamline the EU regulatory framework for medical devices. We urgently call for measures to reduce administrative burden, enhance predictability, and foster innovation and competitiveness, while maintaining the highest standards of patient safety.

APPLiA represents hosehold appliances manufacturers in Europe. More info about us can be found at www.applia-europe.eu. We would like to respond to the Medical devices and in vitro diagnostics targeted revision of EU rules call for evidence with follwoing comments/questions.

This proposal is needed and is a good news,but 2 aspects need to be reviewed : Article 1(1), point (a), of the proposal extension of the validity of certificates : In some third parties' countries it is required to have certificates with valid dates it is critical for the business to have NB re-editing the Certificates with the extended dates Article 1(1), point (b), of the proposal extension of the transition…

There is an oversight within the proposal for transitional arrangements in respect of Annex XVI products that have now been brought within scope of the Medical Regulation. Whilst new Common Specifications have recently been established for such products, they do not benefit from existing conformity certificates under the former Medical Devices Directive.