Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance) (c. 746)

Please note that the date you requested in the address for this web page is not an actual date upon which a change occurred to this item of legislation. You are being shown the legislation from , which is the first date before then upon which a change was made.

ANNEXES

ANNEX XI U.K. CONFORMITY ASSESSMENT BASED ON PRODUCTION QUALITY ASSURANCE

1. The manufacturer shall ensure that the quality management system approved for the manufacture of the devices concerned is implemented, shall carry out final verification, as specified in Section 3, and shall be subject to the surveillance referred to in Section 4. U.K.