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.

View Life Sciences by content type:

News
Practice notes
Precedents
Q&As

Sub Topics We Cover

Medical devices

Latest Life Sciences News

MedTech Europe publishes paper setting out recommendations on the Commission's IVDR revision proposal

MedTech Europe publishes paper setting out recommendations on the Commission's IVDR revision proposal

MedTech Europe has published a paper setting out its recommendations on the European Commission's proposal to revise the Regulation (EU) 2017/746 (In...

EMA adds Q&A section on use of real-world data to regulatory guidance webpage

EMA adds Q&A section on use of real-world data to regulatory guidance webpage

The European Medicines Agency (EMA) has added a questions and answers (Q&A) section to its real-world evidence webpage to clarify regulatory aspects...

Team-NB publishes position paper on medical device certification under MDR

Team-NB publishes position paper on medical device certification under MDR

The European Association of Medical Devices Notified Bodies (Team-NB) has published a position paper on the Medical Device Regulation (MDR)...

Life Sciences weekly highlights—4 June 2026

Life Sciences weekly highlights—4 June 2026

This week's edition of Life Sciences weekly highlights includes news that EFPIA has set out industry priorities for a proposed EU Action Plan on Rare...

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...
Read More >
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...
Read More >
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...
Read More >
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...
Read More >
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...
Read More >
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...
Read More >
2nd Jun
Practice notes

Biotechnology patents

Biotechnology patentsPatenting biotechnological inventionsBiotechnological inventions are, in principle, patentable. While there is no general...
Read More >
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...
Read More >
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...
Read More >
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...
Read More >
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...
Read More >
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...
Read More >
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...
Read More >
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...
Read More >
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...
Read More >
Produced in partnership with Dr. Fiona Kellas of Maucher Jenkins
13th Oct
News

Competition Appeal Tribunal upholds £130m in Allergan fines

...
Read More >
2nd Jun

Popular documents

What is the difference between an appeal and a review?

What is the difference between an appeal and a review?What is an appeal?An appeal in insolvency proceedings is no different to an appeal in normal litigation. An appeal will be allowed only if the appeal court is satisfied that the decision of the lower court was 'wrong' or 'unjust because of a

If a beneficiary signs a deed of disclaimer of their share of an estate and the estate pays their legal

If a beneficiary signs a deed of disclaimer of their share of an estate and the estate pays their legal fees, will that count as a PET against their estate?A disclaimer is the refusal of a gift prior to acceptance. The refusal of the gift must take place before the beneficiary accepts any benefit

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

Can shares in a limited company that have not been paid-up at all be cancelled?

Can shares in a limited company that have not been paid-up at all be cancelled?A limited company having a share capital may not alter that share capital, except in the ways listed in section 617 of the Companies Act 2006 (CA 2006). Shares in a company cannot simply be cancelled without following an