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European Commission

The government state that the MDR will come in to effect in May 2020, and the IVDR in May 2022, however the United States has called upon the EU to delay the implementation of Medical Device Regulations and In Vitro Diagnostic Regulations by 3 years. Read more

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MedTech Europe has released a call to action towards digital health interoperability, endorsing the European Commission‘s Electronic Health Record Exchange Format released on 6 February 2019. Read more

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Industry trade association MedTech Europe has written to EU commissioners highlighting the dangers of Brexit on the medical technology sector. Read more

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The European Commission has revamped its medical device section on its website to include a portal that presents the new regulatory requirements targeted at impacted actors. Read more

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