- Examining the EU legislation for safer medical devices
- Original news
- By way of background, what are the reasons for this reform?
- What are the key features of the two new regulations?
- What are the main changes to the current EU medical devices regime?
- What is the impact of these changes on businesses?
- The European Parliament approved the new rules on 5 April 2017. The new regulations were published in the Official Journal of the European Union on 5 May 2017 and will enter into force 20 days later. The clock has therefore started ticking on the transitional periods of three years in respect of the MDR and five years in respect of the IVDR. Considering that Brexit will happen in March 2019, what are the key considerations for the UK medical devices sector?
IP & IT analysis: On 5 April 2017, the European Parliament adopted new rules for improving the safety of medical devices. Jane Summerfield, counsel at Hogan Lovells International LLP, explores the new regulations, which were published in the Official Journal on 5 May 2017, and considers potential issues with implementation.
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