New MDR EU Medical Device/IVD Regulations - Definition of Importer

nickie

Starting to get Involved
#1
Hi, with reference to the new EU medical device/IVD regulations and the additional responsibilities for all economic operators, I'm not sure about the definition of Importer. The definition according to the regulations is 'importer' means any natural or legal person established within the Union that places a device from a third country on the Union market.

Would you interpret that as including the importation of devices to the UK from another EU state (Brexit notwithstanding :rolleyes:), or only importing devices from outside of the EU into a Union state?

Thank you.
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
For the UK to leave the EU it had to invoke Article 50 of the Lisbon Treaty which gives the two sides two years to agree the terms of the split. Theresa May triggered this process on 29 March, meaning the UK is scheduled to leave on Friday, 29 March 2019. It can be extended if all 28 EU members agree.
(http://www.bbc.com/news/uk-politics-32810887)

For the foreseeable future UK is still a member of the EU and thus movement of goods from the UK to another EU member state is not considered importation.

Added in edit: This may well change by the time the MDR's transition period is over (Nay-June 2020).
 
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