On March 7th, 2017 the Council of the European Union approved two new medical device regulations, including a regulation similar to the US FDA’s UDI rule. The European Parliament is expected to adopt both regulations in April 2017.
To view the EU press release click here.
- 03 Jul 2017HIN Distribution Files Available Online
- 05 Jun 2017FDA Extends UDI Compliance Deadline for Class 1 Devices
- 26 May 2017FDA Posts New Webpage on Use of Symbols in Labeling
- 07 Apr 2017European Parliament Votes to Adopt Medical Device Regulation Proposal
- 03 Apr 2017FDA Grants UDI Extension for Soft Contact Lenses