Small Businesses: UK Trade with EU
The question
To ask the Secretary of State for Business and Trade, if he will take steps to support small businesses with the costs of compliance with (a) EU general safety and performance requirements and (b) EU regulations.
Answered by Justin Madders
UK businesses exporting medical devices to the EU should comply with EU General Safety and Performance Requirements (GSPR), which outline the criteria for medical and in vitro diagnostic devices marketed in the EU. These apply under the EU Medical Device Regulations (MDR) and the In Vitro Diagnostic Regulation (IVDR), which came into force in 2017.
Responsibility for interpreting and providing guidance on EU legislation rests with the European Commission. For detailed guidance, businesses should refer to the European Commission's website. UK Government continue to assess implementation milestones of MDR and IVDR. Businesses experiencing EU market access issues, may seek support via the UK Export Support Service.
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