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European Union › Medical Devices › Regulatory Oversight

The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of... more +
The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of WWII. The EU maintains a common currency as well as several intranational institutions, including the European Parliament and the European Commission. less -
Jones Day

EU Emergency Response Update – Key Policy & Regulatory Developments No. 115

Jones Day on

This regular alert covers key regulatory developments related to EU emergency responses, including in particular to Russia’s war of aggression against Ukraine, COVID-19, and cyber threats. It does not purport to provide an...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q4 2023 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Hogan Lovells

New Medical Devices Regulation in Spain

Hogan Lovells on

On 23 March 2023 the new Spanish Medical Devices Regulation (Spanish MDR) came into force. After a lengthy wait, the medical devices industry (and any other interested sector) finally has access to the final text and knows...more

Hogan Lovells

Key legal concerns for advanced therapy medicinal product (ATMP) sponsors in Europe

Hogan Lovells on

In recent years we have seen more and more gene and cell therapies coming successfully to market – but many more such candidates have not made it to market, or been unable to obtain sufficient reimbursement. Gene and cell...more

Epstein Becker & Green

[Webinar] Shaping the Future of Artificial Intelligence (AI) Within Life Sciences - September 30th, 9:00 am - 10:15 am ET

Epstein Becker & Green on

Amy Dow and Brad Thompson, Members of the Firm, speak on “Shaping the Future of Artificial Intelligence (AI) Within Life Sciences,” a virtual program co-hosted by Simmons & Simmons and Epstein Becker Green. On both sides of...more

Hogan Lovells

Draft text of new Spanish regulation on medical devices is opened for contributions

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The Spanish Ministry of Health has initiated the hearing and public information process for the new regulation on medical devices. The draft text will be available for contributions by 10 July 2021. The direct application of...more

Hogan Lovells

The European Commission proposes a new Pharmaceutical Strategy for the EU

Hogan Lovells on

On 25 November 2020, the European Commission published a proposal for a new Pharmaceutical Strategy for Europe (“the Strategy”). The Strategy is built around four main objectives, each with an assigned work strand....more

Hogan Lovells

MDCG guidance for consultations of authorities on devices incorporating a medicinal product

Hogan Lovells on

On 10 June 2020, the MDCG issued guidance MDCG 2020-12 on the transitional provisions concerning the consultation of authorities regarding devices incorporating a substance.....more

Hogan Lovells

European Commission announced its plan to postpone the implementation of the MDR by one year

Hogan Lovells on

The European Commission today announced that it is preparing a proposal to postpone the entry into application of the new Medical Devices Regulation (MDR). The proposed postponement would be for one year....more

Hogan Lovells

COVID-19: Daily Report for Life Sciences and Health Care Companies

Hogan Lovells on

The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the world to help life sciences and health care companies stay current in this challenging time. ...more

Hogan Lovells

New medical device regulation in Spain opened for public consultation

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Spain’s Ministry of Health initiated proceedings for approval of the new regulation on medical devices with a call for a prior public consultation to receive contributions from interested parties....more

Hogan Lovells

New MDCG Guidance on Summary of Safety and Clinical Performance under the Medical Devices Regulation (MDR)

Hogan Lovells on

On 26 September 2019, the European Commission published a new Guidance of the Medical Device Coordination Group (MDCG) concerning the Summary of Safety and Clinical Performance (SSCP). This document is aimed at manufacturers...more

Hogan Lovells

Publication of rules on designation of expert panels under the Medical Devices Regulations

Hogan Lovells on

In the process of getting ready for the implementation of the forthcoming medical devices Regulations the European Commission published on 10 September 2019 the Commission Implementing Decision (EU) 2019/1396 (Decision)...more

Hogan Lovells

European Commission draft implementing regulation on the reprocessing of single-use medical devices: public consultation is open!

Hogan Lovells on

On 23 July 2019, the European Commission published the draft Commission Implementing Regulation (hereafter “Draft”) regarding Common Specifications for the reprocessing of single-use medical devices....more

McDermott Will & Emery

Digital Health in the United Kingdom: The New Regulatory Environment Under the Medical Device Regulation

McDermott Will & Emery on

The MDR and other recent developments in the health care regulatory landscape pose new opportunities and challenges for medical software companies and investors in digital health in the United Kingdom. Although the regulatory...more

Hogan Lovells

Brexit snapshot: Medical Devices

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Do you hold a CE certificate of conformity issued by a UK notified body? Are your manufacturing activities, authorised representative, suppliers, customers or contracting parties located in the UK? ...more

Hogan Lovells

New Brexit Q&A provides several examples in relation to the “placing on the EU market” of products including medical devices

Hogan Lovells on

On 1 February 2019, the European Commission published a new Q&A document to give further guidance on the Notice to stakeholders-withdrawal of the United Kingdom and EU rules in the field of industrial products (“the Notice”)....more

Hogan Lovells

New Brexit Q&A provides several examples in relation to the “placing on the EU market”of products including medical devices

Hogan Lovells on

On 1 February 2019, the European Commission published a new Q&A document to give further guidance on the Notice to stakeholders-withdrawal of the United Kingdom and EU rules in the field of industrial products (“the Notice”)....more

Hogan Lovells

New Belgian legislation on the distribution of medical devices

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Today, the Belgian Minister of Health published the new Royal Decree of 19 December 2018 on the liberalisation of the distribution circuit for medical devices....more

Hogan Lovells

European Commission publishes factsheet on the (in vitro) medical devices procurement ecosystem

Hogan Lovells on

The European Commission has published a factsheet addressed to organisers of public tenders involving medical devices. The goal of the factsheet is to provide hospitals, clinics, ministries and competent authorities...more

Hogan Lovells

European Commission publishes factsheet on medical devices and in vitro medical devices for non-EU and non-EEA competent...

Hogan Lovells on

Introduction The European Commission has published a factsheet addressed to competent authorities of third countries....more

Hogan Lovells

The European Commission publishes nine new guidance documents in relation to the MDR and IVDR

Hogan Lovells on

On 20 November 2018, the European Commission published nine new documents intended to provide guidance to non-EU authorities and economic operators in relation to the Medical Devices Regulation (“MDR”) and In vitro Diagnostic...more

Hogan Lovells

New “rolling plan” and new guidance documents in relation to the MDR and IVDR

Hogan Lovells on

The European Commission just published an “implementing measures rolling plan” in relation to the MDR and IVDR which are scheduled to apply from 26 May 2020 and 26 May 2022 respectively....more

Hogan Lovells

UK MHRA consults on no-deal Brexit legislation

Hogan Lovells on

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has initiated a consultation on the legislation and regulatory processes for medicines, medical devices and related clinical trials that would need to be...more

Hogan Lovells

HMA-EMA’s work programme on availability of authorised medicines for human and veterinary use includes measures for Brexit

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On 23 August 2018, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA), the network of the National Competent Authorities in the European Economic Area (EEA), published the work programme of their...more

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