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Medical Devices European Economic Area (EEA)

MoFo Life Sciences

EU MDR And IVDR Implementation: New Transitional Regime Enters Into Force

MoFo Life Sciences on

On March 20, 2023, the new transitional regime for medical devices in the EU and the EEA became effective when Regulation (EU) 2023/607 (the “Regulation”) was published in the Official Journal of the European Union. The...more

Cooley LLP

European Commission Proposes Amending Transitional Provisions in Medical Devices and In Vitro Diagnostics Regulations

Cooley LLP on

On 6 January 2023, the European Commission adopted a proposal to amend the transitional provisions of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - June 2021

Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more

Hogan Lovells

The AFMPS further extends measures to combat shortages of medicinal products by another month

Hogan Lovells on

On 29 May 2020, the AFMPS issued a new decision which further extends the measures initially provided in the Decision 1 April 2020 concerning supply of specific medicinal products by another month. These measures were...more

Hogan Lovells

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

Hogan Lovells on

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

WilmerHale

Brexit at Halfway: Pharma and Medical Devices

WilmerHale on

The object of this Alert is to highlight some practical implications of Brexit for the supply of pharmaceutical products and medical devices in the European Union (EU) and related action items which companies should be...more

Jones Day

Update on Recommendations and Initiatives of EU Regulators Ahead of Brexit

Jones Day on

On April 27, 2017, the European Medicines Agency ("EMA") held a meeting with the heads of the National Competent Authorities ("NCAs") of the European Union ("EU")/European Economic Area ("EEA") Member States to discuss the...more

Knobbe Martens

The Brexit Effect on Medical Devices

Knobbe Martens on

The medical device industry has been struck by a wave of uncertainty in the wake of the United Kingdom’s (UK) historic vote to leave the European Union (EU). Until the breakup becomes official, British legislation should...more

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