MDCG 2019-15 Guidance Notes Class I Medical Devices

The purpose of this document is to provide guidance to manufacturers of Class I medical devices (other than custom made devices) to help them meet the provisions of the MDR. This guidance should also be applicable for situations when an importer, distributor or any other legal person assumes the obligations incumbent on manufacturers, as per Article 16 (1), while not covering the exception indicated by Article 16 (2).

 

The MDR has changed the scope of the medical device legislation and it now extends its application to all economic operators in the supply chain (manufacturer, authorised representative, importer and distributor) as well as a broadened range of products such as those specifically intended for the cleaning, disinfection or sterilization of devices (Article 2 (1)) and products without an intended medical purpose (such as certain aesthetic products, as indicated in Annex XVI of the MDR). In addition, more emphasis is placed on a life-cycle approach to safety, backed up by clinical data and new requirements such as transparency and traceability.

 

Before placing a device on the market, the manufacturer will affix the CE mark in accordance with Annex V and draw up the EU declaration of conformity, including all the information required by Annex IV. Prior to that, the manufacturer will demonstrate conformity with the MDR and compliance with the applicable general safety and performance requirements laid out in Annex I.

 

You will find the complete document "MDCG 2019-15 Guidance Notes For Manufacturers of Class I Medical Devices" here.