The MHRA is seeking views on its approach to implementing into UK law the Commission Regulations 722/2012 on animal tissues and Commission Regulation 207/2012 on e-labelling.

 

Commission Regulation 722/2012 replaces the existing requirements (contained in Directive 2003/32) placed on medical devices manufactured utilising non-viable tissues from Transmissible Spongiform Encephalopathies (TSE)-susceptible species. The affected animals are bovine, ovine and caprine species, deer, elk, mink and cats.

 

Commission Regulation 207/2012 enables manufacturers to supply instructions for use electronically for certain categories of general medical devices and active implantable medical devices should manufacturers so wish.

 

The deadline for responses is 7 May 2013. Please send responses by email to rebecca.brown@mhra.gsi.gov.uk.

 

Public consultation on Medical Devices (Amendment) Regulations 2013.

 

Posted on the UK MHRA website on 9 April 2013