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Manufacturers Regulatory Oversight United Kingdom

K&L Gates LLP

PFAS and Other Emerging Alleged Contaminants Litigation: Mitigating Risk Through Insurance

K&L Gates LLP on

The United States (US) has seen an explosion of litigation in recent years relating to perfluoroalkyl and polyfluoroalkyl substances (PFAS), referred to by some as “forever chemicals” because they are slow to degrade and can...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

McDermott Will & Emery

UK Medical Device Regulator Proposes a 12 Month Delay for UKCA Requirements and the New Medical Device Regulations

McDermott Will & Emery on

On Friday 21st October 2022, the Medicines and Healthcare Products Regulatory Agency (MHRA) wrote to the medical device industry to explain its intention: - To extend the current standstill period by twelve months from...more

Hogan Lovells

Publication of further guidance on the role of the “UK Responsible Person” in case of no-deal Brexit

Hogan Lovells on

On 18 September 2019, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance regarding the role and responsibilities of the “UK Responsible Person”. ...more

BCLP

Strategic Modern Slavery and Human Rights Risk Management: The UK Modern Slavery Act Four Years on

BCLP on

When the Modern Slavery Act (“Act”) came into force in October 2015, it was the first legislation of its kind, aiming to tackle and eventually eliminate human trafficking and the various forms of modern slavery. It also...more

McDermott Will & Emery

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

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

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

What would a no-deal Brexit look like for the UK chemicals industry?

Hogan Lovells on

The UK government has recently published a technical notice to guide businesses that produce, register, import or export chemicals on what they will need to do if the UK leaves the EU in March 2019 in a 'no deal' scenario...more

Hogan Lovells

Updated EMA guidance on centrally authorised medicines raises new considerations for Brexit preparations

Hogan Lovells on

On 19 June 2018, the European Medicines Agency (EMA) published updates to its Brexit Q&A document for human and veterinary medicines authorised via the centralised procedure and to its practical procedural guidance on making...more

Hogan Lovells

Brexit – what’s next for medical devices?

Hogan Lovells on

On 22 January 2018, the European Commission released a notice to stakeholders concerning the United Kingdom’s (“UK”) possible withdrawal from the European Union (“EU”) and the EU rules in the field of industrial products,...more

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