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EU: Regulation 2017/746 — Amended transitional provisions for certain in vitro diagnostic medical devices

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In brief

On 28 January 2022 Regulation (EU) 2022/112 (“Regulation”) amending Regulation (EU) 2017/746 on in vitro diagnostic medical devices (“IVDR”) was published in the Official Journal of the EU.

Contents

  1. Key Takeaways

Key Takeaways

In particular, the Regulation introduces longer transitional periods with respect both to the validity of certificates issued by notified bodies in accordance with Directive 98/79/EC (“IVDD”) and for the making available on the market and putting into service of in vitro diagnostic medical devices lawfully placed on the market pursuant to the same IVDD. Conversely, safety and performance requirements set forth in the IVDR and its application date, scheduled for 26 May 2022, remain unchanged.

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Author

Roberto Cursano has been a lawyer in Baker McKenzie since September 2007. He focuses on healthcare law and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts. Mr. Cursano is a former administrative officer in the Italian Ministry of Health and helps clients work closely with the Italian Public Administration. He is admitted to the bar before the Italian Supreme Court and the Council of State. As well as training and tutoring in the master’s degree program on clinical trials of pharmaceutical products at the University of Rome Sapienza, Mr. Cursano regularly publishes articles and scientific contributions. He also frequently hosts and participates in seminars and presentations on pharmaceutical and administrative law matters.

Author

Riccardo Ovidi is an Associate in Baker McKenzie Rome office.

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