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
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
4/18/2025
/ Artificial Intelligence ,
Compliance ,
Data Privacy ,
Data Security ,
Digital Health ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Pharmaceutical Industry ,
Popular ,
Regulatory 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
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
9/25/2020
/ Life Sciences ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Member State ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Regulatory Oversight ,
Regulatory Reform ,
Regulatory Requirements ,
UK ,
UK Brexit
Following the recent agreement to delay Brexit until 31 January 2020, the UK Department of Health and Social Care ("DHSC") has written to suppliers of UK medicines and medical devices to confirm the continued contingency...more
11/8/2019
/ Border Security ,
Contingency Plans ,
Cross-Border Transactions ,
Customs ,
EU ,
Imports ,
Medical Devices ,
Member State ,
No-Deal Brexit ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Procurement Policies ,
Regulatory Requirements ,
Strategic Planning ,
Supply Chain ,
UK Brexit ,
Withdrawal Agreement
The UK Government has published guidance for life sciences companies on the Brexit implementation period, which is intended to take effect from 30 March 2019 to the end of 2020. ...more