Disputes and regulatory enforcement

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Disputes and regulatory enforcement

Latest Life Sciences News

The draft Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024

The draft Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024

The following Life Sciences news provides comprehensive and up to date legal information on The draft Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024

Life Sciences weekly highlights—21 November 2024

Life Sciences weekly highlights—21 November 2024

The following Life Sciences news provides comprehensive and up to date legal information on Life Sciences weekly highlights—21 November 2024

MHRA announces relaunch of Innovative Licensing and Access Pathway for 2025

MHRA announces relaunch of Innovative Licensing and Access Pathway for 2025

NICE reveals scientific advice service reduces appraisal timelines

NICE reveals scientific advice service reduces appraisal timelines

Featured Life Sciences content

The regulation of medical devices in the UK

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...

Regulation of e-cigarettes

Regulation of e-cigarettes

Regulation of e-cigarettes31 December 2020 marked the end of the Brexit implementation period following the UK’s decision to withdraw from the EU. At...

Clinical evaluation and performance evaluation of medical devices in the EU

Clinical evaluation and performance evaluation of medical devices in the EU

Clinical evaluation and performance evaluation of medical devices in the EUThis Practice Note describes key changes to the requisite clinical...

Unlicensed medicinal products and off-label use of medicinal products

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...

Practice notes

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...

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Produced in partnership with Andrew Bowler of Bristows and Adrian Chew of Bristows

1st Mar

Practice notes

Post-market surveillance of medical devices in the EU

Post-market surveillance of medical devices in the EUPost-market surveillance is the monitoring by manufacturers of medical devices to ensure their...

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Produced in partnership with Alison Dennis of Taylor Wessing LLP

1st Mar

Practice notes

Intellectual property protection for medical devices

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

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Produced in partnership with Reuben E. Jacob of Maucher Jenkins and Dr Edward Rainsford of Maucher Jenkins

1st Mar

Practice notes

Medicines and Medical Devices Act 2021

Medicines and Medical Devices Act 2021This Practice Note provides an overview of the Medicines and Medical Devices Act 2021 (MMDA 2021) which, in...

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1st Mar

Practice notes

Introduction to borderline products

Introduction to borderline productsThis Practice Note provides an introduction to the concept of borderline products, how the regulatory status of...

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2nd Mar

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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1st Mar

Practice notes

Pharmacovigilance

PharmacovigilancePharmacovigilance is the process of collecting and understanding information relating to the adverse effects of medicinal product...

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Produced in partnership with Eveline Van Keymeulen of Latham & Watkins and Jeanne Fabre of Latham & Watkins

2nd Mar

News

The UK medical devices regime and the impact of the Northern Ireland Protocol

Life Sciences analysis: Peter Rudd-Clarke, partner, and Anna Lundy, associate director, at Osborne Clarke discuss how the medical device industry is...

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2nd Mar

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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2nd Mar

News

Life Sciences weekly highlights—11 August 2022

This week's edition of Life Sciences weekly highlights includes analysis of the English court’s jurisdiction to decide COVID-related business...

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2nd Mar

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 Geneviève Michaux of King & Spalding

2nd Mar

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 Selina Badiani of Bristows and Charlie French of Bristows LLP

1st Mar

News

Life Sciences weekly highlights—18 August 2022

This week's edition of Life Sciences weekly highlights includes consideration of the arguments put forward against DeepMind, Google’s subsidiary, for...

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2nd Mar

Practice notes

Pharma and medical device regulation—Colombia—Q&A guide

Pharma and medical device regulation—Colombia—Q&A guideThis Practice Note contains a jurisdiction-specific Q&A guide to pharma and medical device...

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2nd Mar

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

1st Mar

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

2nd Mar

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

Early leavers—preservation

Early leavers—preservationFORTHCOMING DEVELOPMENT: Section 10 of the Finance Act 2022 will increase the normal minimum pension age (NMPA) from 55 to 57 on 6 April 2028 (save for members of the firefighters, police and armed forces public service pension schemes).The Finance Act 2022 will also give

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

Contributory negligence in personal injury claims

Contributory negligence in personal injury claimsContributory negligence is a partial defence which can lead to a discount in damages.Other defences may also be relevant. See Practice Notes: Did the claimant consent to the risk of injury? and Was the claimant involved in an illegal activity?If a