[Emergo, UL] The new Great Britain vigilance report schema goes live

The new Great Britain (GB) vigilance report schema goes live on Monday, June 16 in alignment with the timing of the new post-market surveillance (PMS) regulations coming into force. The GB regulator has updated its online guidance hub with resources intended to assist with the implementation of the new schema.

 

The Medicines and Healthcare products Regulatory Agency (MHRA) has long leveraged the European Union (EU) vigilance report form schema for report intake and submission in their online reporting portal: the Manufacturer Online Reporting Environment (MORE). Data from version 7.2.1 of the EU form will be accepted until October 16.

 

Due to Brexit, GB was removed from the distribution countries identified in version 7.3.1 of the EU form. Only reports for Northern Ireland will transition to the new version 7.3.1 form in November and, ultimately, submission in the European database for medical devices, EUDAMED, upon completion of the vigilance module. XML files exported from the 7.3.1 template will not validate in MORE.

 

 

The new Great Britain vigilance report schema goes live | Emergo by UL

The new Great Britain vigilance report schema goes live