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Be vigilant: new post-market surveillance requirements for medical devices in Great Britain take effect

The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (PMSR), which were passed into law on 22 October 2024, came into force today (16 June 2025), amending the UK’s Medical...more

Life Sciences & Health Care Horizons 2025

Our 2025 Life Sciences and Health Care Horizons edition is now live! Explore the latest global insights from the U.S., Asia-Pacific, Europe, Latin America, and the Middle East on the key issues and emerging trends shaping the...more

MHRA publishes guidance on to new UK medical device post-market surveillance requirements

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a suite of guidance specifically designed to help medical device manufacturers understand and prepare for the new post-market surveillance (“PMS”)...more

Life Sciences Law Update - Key developments for pharma and medical device companies in EU and Germany, France, UK, Italy and Spain...

Pharma: Launch of Shortages Monitoring Platform, several Changes re Clinical Trial Management in EU Countries; Devices: Resolution on the need to revise the MDR and IVDR published; Compliance: CSRD still not implemented in...more

Updated roadmap for UK medical device reforms published by the MHRA

On 11 December 2024, the MHRA published a revised roadmap for the long-awaited reforms to the UK Medical Device Regulations 2002 (MDR Roadmap). The updated MDR Roadmap provides additional clarity for industry on the intended...more

MHRA confirms five technologies selected for AI Airlock Pilot

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced the five technologies selected to participate in the ‘AI Airlock Pilot’ for AI-powered medical devices. The pilot is a regulatory “sandbox” for...more

Framework amending the UK clinical trial regulations laid before Parliament

On 12 December 2024 the statutory instrument to amend the Medicines for Human Use (Clinical Trials) Regulations 2004 (UK CTR) was laid before Parliament. The Medicines and Healthcare products Regulatory Agency (MHRA),...more

MHRA opens consultation on future routes to market and IVDs under the UK medical device regulations

The MHRA has opened a consultation on proposed future pre-market requirements for medical devices and in vitro diagnostic devices (IVDs) in Great Britain. The consultation expands on proposals considered in the MHRA’s 2021...more

Legislation introduced to strengthen UK post-market surveillance requirements for medical devices

A draft Statutory Instrument was laid before UK Parliament on 22 October 2024 which, once passed, will introduce new post-market surveillance (PMS) requirements for medical devices and in vitro medical devices (IVDs) in the...more

10/29/2024  /  Manufacturers , Medical Devices , UK , WTO

Q2/2024 Life Science Law Update – Key developments for pharma & device companies in EU

The Q2/24 Life Science and Health Care Law Update covers key trends in the EU and Big Five (France, Germany, Italy, Spain, UK) in life sciences regulatory, corporate, compliance, competition, and privacy....more

Panelists discuss European pharmaceutical trends and how to stay ahead of the game - Life Sciences and Health Care Horizons event...

We were pleased to welcome industry leaders to our Life Sciences and Health Care Horizons event in Zurich, where co-head of Hogan Lovells Life Sciences and Health Care sector Jane Summerfield, and partners Melissa K. Bianchi,...more

UK MHRA publishes blueprint for the international recognition of medical devices

The UK Medicines and Healthcare products Regulatory Agency (MHRA's) has published a Statement of policy intent: international recognition of medical devices outlining its proposal for the International Recognition Procedure...more

UK MHRA Publishes AI Regulatory Strategy

On 30 April 2024, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) published its strategic approach to AI and the steps it is taking to implement the UK Government's AI White Paper, published in August 2023....more

2024 Life Sciences & Health Care Horizons

While economic factors, including the high cost of capital, continue to keep our clients up at night, we also see signs of optimism in 2024. Against this fiscal backdrop, significant recent regulatory changes and those on the...more

UK: a new medical devices regime on the horizon?

The UK Government has recently made available a draft of the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2023 (2023 Regs). Although these are far from being in force yet,...more

UK MHRA medical device standstill extension commences

Today marks the commencement of the legislation that extends the standstill period for EU CE-marked medical devices to continue to be placed on the market in Great Britain (England, Wales and Scotland)....more

MHRA Update on UK medical device legislation reform and transition

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an update on the timing of the reform of the current UK legislation, the Medical Device Regulations 2002 (UK MDR), and the transitional arrangements...more

UK MHRA delays new medical devices legislation until July 2024

The United Kingdom medical devices regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has announced that the upcoming changes to UK medical device legislation will be pushed back from 1 July 2023 to 1...more

Safety first: MHRA response to UK medical device regulation consultation

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its response to its consultation on the future regulation of medical devices in the United Kingdom which ran between September and November...more

UK regulation of medical devices from 1 January 2021

The UK Medicines and Healthcare products Regulatory Agency ("MHRA") has published new guidance (the "Guidance") on how medical devices will be regulated in Great Britain ("GB") (England, Wales and Scotland) and in Northern...more

COVID-19: Daily Report for Life Sciences and Health Care Companies

The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the world to help life sciences and health care companies stay current in this challenging time. ...more

NHS medicine and device suppliers urged to carry out supply chain coronavirus risk assessment

At the end of last week, the World Health Organisation (WHO) upgraded the global risk assessment of the novel coronavirus to "very high." This comes shortly after the United Kingdom saw its first fatality as a result of...more

Highlights from the DigiHealth Leaders Conference: interoperability, reimbursement, patient centricity, and forging effective...

Digital health offers huge potential for improving care and alleviating the increasing burden on our over-stretched healthcare systems. However, its uptake remains slow and varies significantly across the EU....more

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