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New sort of applicable economic operators regulation: the Market Surveillance Regulation and its impact on medical devices industry

New sort of applicable economic operators regulation: the Market Surveillance Regulation and its impact on medical devices industry
Published on: 20 August 2019
Published by: LexisPSL
  • New sort of applicable economic operators regulation: the Market Surveillance Regulation and its impact on medical devices industry
  • Only insofar as it depends
  • Fulfillment service providers (Article 4)
  • Distance sales (Article 6)
  • Small bombshell in Article 11 (9): Lycocentre revisited
  • Recovery of costs by market surveillance authorities (Article 15)
  • Procedural rights of economic operators (Article 18)
  • Market surveillance
  • Date of application

Article summary

Life Sciences analysis: In previous discussions regarding economic operators, it has been noted that essential parts of the general Goods Package were being amended and that this may affect companies in the medical devices space. The latest change in this area has been Regulation (EU) 1020/2019 of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011, the Market Surveillance Regulation. This regulation replaces part of Regulation 765/2008 (Articles 15–29), the regulation that set up the economic operator regime under the Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), and further supplements many other EU CE marking directives and regulations. Erik Vollebregt of Axon Lawyers discusses the Market Surveillance Regulation. or take a trial to read the full analysis.

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