CENTRO DI DOCUMENTAZIONE SUI DISPOSITIVI MEDICI

MDD REGULATION TRANSITION TIME - STOP THE CLOCK (?) MedTech Europe   -  Original publisher MedTech Europe is calling on the European Commission, European Parliament and all EU Member States, to have an urgent discussion of solutions that will ensure that there is appropriate time for the systems to be ready to function. The industry calls for: • Actions to address challenges on the transition timing Industry envisages at least three options to be explored either alone or in combination: a) A ‘stop the clock’ mechanism, that freezes the remaining transition time for both regulations until full readiness of the system has been achieved; b) An extension of the critical dates of 26 May 2020 and 26 May 2022, for all products; c) An extension of the critical dates of 26 May 2020 and 26 May 2022, for legacy products only. Options b) and c) would require a specific timeline to be agreed upon. • Actions to make the ‘grace period’ an effective instrument and...

Many products require CE marking before they can be sold in the  EEA  ( EU + Iceland, Lichtenstein and Norway). CE marking proves that your product had been assessed and meets EU safety, health and environmental protection requirements. It is valid for products manufactured both inside and outside the EEA, that are then marketed inside the EEA. To affix the CE marking to your product, you must put together a technical dossier proving that your product fulfils all the EU-wide requirements. As the product's manufacturer, you bear sole responsibility for declaring conformity with all requirements. Once your product bears the CE marking, you might have to provide your distributors and/or importers with all the supporting documentation concerning CE marking. More information>Click Here