Medical devices

Stay ahead in the dynamic landscape of medical device regulation with expert guidance tailored for legal professionals in Life Sciences. Addressing core issues such as compliance, market authorisation, and product liability, our resources provide invaluable insights to streamline your practice. Access up-to-date information and strategic advice to confidently manage the legal intricacies of medical devices, ensuring your clients thrive amidst evolving regulatory demands.

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Medical devices

Latest Life Sciences News

Commission launches COMBINE programme phase 2 pilot for combined medicine-device studies

Commission launches COMBINE programme phase 2 pilot for combined medicine-device studies

The European Commission and the competent authorities of EU Member States have launched phase 2 of the COMBINE pilot coordinated assessment procedure...

Life Sciences weekly highlights—25 June 2026

Life Sciences weekly highlights—25 June 2026

This week's edition of Life Sciences weekly highlights is a relatively light news cycle that includes an analysis of the Tobacco and Vapes Act 2026...

Commission publishes revised Annex 19 GMP guidance on reference and retention samples

Commission publishes revised Annex 19 GMP guidance on reference and retention samples

The European Commission has published a revised version of Annex 19 of the EU Guidelines for Good Manufacturing Practice (GMP) for Medicinal Products...

European Parliament calls for suspension of UWWTD EPR obligations and new Commission impact assessment

European Parliament calls for suspension of UWWTD EPR obligations and new Commission impact assessment

The European Parliament has adopted a resolution calling for a temporary suspension of the Extended Producer Responsibility (EPR) provisions under the...

Featured Life Sciences content

Introduction to technology transfer agreements in the Life Sciences industry

Introduction to technology transfer agreements in the Life Sciences industry

Introduction to technology transfer agreements in the Life Sciences industryWhat is a technology transfer agreement?The term ‘technology transfer...

Regulation of cosmetic products in the UK

Regulation of cosmetic products in the UK

Regulation of cosmetic products in the UKThis Practice Note provides an overview of the UK regulatory framework for cosmetics. It sets out the legal...

Intellectual property protection for medical devices

Intellectual property protection for medical devices

Intellectual property protection for medical devicesChanges to intellectual property (IP) law from 1 January 2021Before discussing how intellectual...

Second and subsequent medical use patent claims

Second and subsequent medical use patent claims

Second and subsequent medical use patent claimsBackground to medical use claimsSecond (and subsequent) medical use patent claims are specific to the...

Practice notes

The experimental use and Bolar-type exemptions to patent infringement

The experimental use and Bolar-type exemptions to patent infringementPatent systems are intended to foster innovation, not to impede it. For this...
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Produced in partnership with Charlie French of Bristows and Milly Wickson of Bristows
13th Oct
tag iconIn-house
News

The 2024 ABPI Code of Practice—what are the key proposed changes?

The PMCPA has recently launched a consultation to update:•the 2021 ABPI Code of Practice•the Constitution and Procedure which sets out how the PMCPA...
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3rd Jun
Precedents

Clinical Research Organisation (CRO) master services agreement

Clinical Research Organisation (CRO) master services agreementDATA PROTECTION NOTICE: Please note that the drafting of clause 7 (Data Protection), in...
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30th May
Practice notes

The EU Clinical Trials Regulation

The EU Clinical Trials RegulationThis Practice Note looks at Regulation (EU) 536/2014, the EU Clinical Trials Regulation (CTR), which governs clinical...
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Produced in partnership with Eveline Van Keymeulen of Latham & Watkins and Jeanne Fabre of Latham & Watkins
13th Oct
Precedents

Medical devices due diligence questionnaire

Medical devices due diligence questionnaireIntroductionThis medical devices regulatory due diligence questionnaire relates to the proposed purchase by...
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30th May
Flowcharts

Lifecycle of a medical device—flowchart

Lifecycle of a medical device—flowchartThis Flowchart illustrates the typical lifecycle of a medical device. The lifecycle identifies eight key stages...
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2nd Jun
Practice notes

Biotechnology patents

Biotechnology patentsPatenting biotechnological inventionsBiotechnological inventions are, in principle, patentable. While there is no general...
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Produced in partnership with Nicole Jadeja of Pinsent Masons and Christopher Leung of Fieldfisher
13th Oct
Practice notes

Unlicensed medicinal products and off-label use of medicinal products

Unlicensed medicinal products and off-label use of medicinal productsThis Practice Note explores unlicensed medicinal products and the various ways...
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Produced in partnership with Dr Peter Feldschreiber of 4 New Square
13th Oct
News

MHRA releases guidance on pharmacovigilance following Windsor Framework agreement

The Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance on the implementation of changes to pharmacovigilance for...
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3rd Jun
Practice notes

The regulation of medical devices in the UK

The regulation of medical devices in the UKThis Practice Note provides an overview of the UK regulatory regime for medical devices. It explains the...
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30th May
tag iconBrexit
News

Court of Appeal allows appeal in British Standards v RRR Manufacturing

The National Archives has published the judgment in British Standards Institution v RRR Manufacturing Pty Ltd, R (on the application of) [2024] EWCA...
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3rd Jun
News

CMA announces Phase 1 merger inquiry into Roche Diagnostics

The Competition and Markets Authority (CMA) has announced a Phase 1 merger inquiry into Roche Diagnostics Ltd's acquisition of point-of-care testing...
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3rd Jun
News

DSIT publishes international scientific report on advanced AI safety

The Department for Science, Innovation and Technology (DSIT) has released the interim International Scientific Report on the Safety of Advanced...
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3rd Jun
Practice notes

The regulation of advanced therapy medicinal products

The regulation of advanced therapy medicinal productsThe development of medicine, biomicrobiology and biotechnology has led to the emergence of a...
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Produced in partnership with Alexander Roussanov of Arnold & Porter and Heba Jalil of Arnold & Porter
13th Oct
Practice notes

Intellectual property protection for digital health

Intellectual property protection for digital healthThis Practice Note discusses the various intellectual property (IP) rights that can be used to...
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Produced in partnership with Dr. Fiona Kellas of Maucher Jenkins
13th Oct
News

Competition Appeal Tribunal upholds £130m in Allergan fines

...
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2nd Jun

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Priority between loss reliefs in loss making companies

Priority between loss reliefs in loss making companiesWhy does it matter?A company that is a member of a group and has incurred any of the types of losses available for surrender by way of group relief may, without any further rules, have more than one way in which to use the loss. There are a

Late payment penalties—inheritance tax

Late payment penalties—inheritance taxWhile interest often accrues on overdue tax, the late payment of certain taxes may also attract a penalty. For information on the interest accruing on overdue tax, see Practice Notes: IHT—payment deadlines on death—Interest on IHT and Interest on late paid

Strike out—making an application to strike out a statement of case

Strike out—making an application to strike out a statement of caseA strike out order can be made either following an application by the parties or on the court's own initiative. This Practice Note deals with the scenario of the order being made following a party's application.Making an application

Glossary—Latin legal terms

Glossary—Latin legal termsDespite attempts in recent years to simplify the language used in legal cases, there are still a number of Latin phrases commonly used in personal injury claims. The following Latin phrases are listed in alphabetical order:Latin