News & Analysis as of

United Kingdom Manufacturers Medicines and Healthcare Products Regulatory Agency (MHRA)

McDermott Will & Schulte

MHRA announces changes to international reliance and in vitro diagnostic devices rules

In late July 2025, the UK government published its response to a consultation held between November 2024 and January 2025 about international reliance, UK Conformity Assessed (UKCA) marking and in vitro diagnostic devices. In...more

Hogan Lovells

Key takeaways – UK MHRA’s response to consultation on ‘Medical Devices Regulations: Routes to market and in vitro diagnostic...

Hogan Lovells on

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its responses to the consultation on Medical Device Regulations: Routes to market and in vitro diagnostic devices carried out last year....more

Hogan Lovells

Regulation for medicines manufactured at the point of care introduced before UK Parliament

Hogan Lovells on

The UK's Medicines and Healthcare products Regulatory Agency ("MHRA") has announced first-of-its-kind legislation to better facilitate the manufacture and delivery to patients of medicines that are manufactured at or near the...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 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

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 & Schulte

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

McDermott Will & Schulte 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

Shook, Hardy & Bacon L.L.P.

COVID-19 Client Primer | UK Medical Device Product Liability

ANALYSIS - Product Liability Risks for Medical Devices in the UK - In order to fast-track the development, manufacture and supply of key medical equipment and devices vital in the fight against COVID-19, governments,...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

Pillsbury - Global Sourcing Practice

Outsourcing in the Pharmaceutical and Life Sciences Sectors – A UK Perspective

Pharmaceutical and Life Sciences companies operate in a demanding environment and face diverse challenges such as pricing pressure, increased regulatory requirements and mounting costs. With this backdrop, they have, starting...more

Hogan Lovells

The MHRA issues new guidance concerning Own Brand Labelling or "Virtual Manufacturing"

Hogan Lovells on

On 29 March 2017, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published a new guidance (hereafter “Guidance“) concerning the Own Brand Labelling of medical devices in the United Kingdom. The Guidance,...more

Hogan Lovells

UK MHRA to develop quality standards for biological medicines

Hogan Lovells on

The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological medicines....more

Hogan Lovells

UK MHRA publishes “top tips” for manufacturing authorisation applicants

Hogan Lovells on

The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published guidance for companies submitting a Manufacturing Authorisation application or variation on common mistakes made by applicants, to help reduce...more

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