Factsheet of the European Commission of Class I medical devices under Regulation (EU) 2017/745

Are you a manufacturer of Class 1 medical devices? What you need to know about Regulation (EU) 2017/ 745 is summarized in the fact sheet published by the European Commission.

This factsheet covers devices that have already been placed on the market under Directive 93/42/EEC and new devices intended to be placed on the market for the first time in accordance with Regulation (EU) 2017/745 of the European Parliament and the Council of 5 April 5, 2017.

This factsheet specifies the change in classification rules, the new applicable requirements, a step-by-step approach for Class 1 medical device compliance, and a FAQ.

DOWNLOAD THE FACTSHEET: CLASS 1 MEDICAL DEVICES UNDER REGULATION (EU) 2017/745