Scope of Regulatroy changes for 2023
Regulatory compliance in the UK medical market has undergone significant changes in 2023, primarily driven by the post-Brexit transition away from the European Union’s legal and regulatory systems. Here’s a comprehensive overview for a blog post on this topic:
Introduction
In 2023, the UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) has been the cornerstone of major regulatory shifts in the medical devices market. This transformation is part of a broader move to establish an independent regulatory framework following Brexit.
Key Regulatory Changes
- MHRA’s Central Role: The MHRA is responsible for regulating the UK medical devices market, emphasising patient safety and supporting industry and patients within the operating environment.
- Legislation Amendments: The UK government amended The Medical Device Regulations 2002 to extend the acceptance of CE-marked medical devices on the Great Britain market.
- CE Mark Transition: A significant change is the phasing out of CE marks, which, until June 30, 2023, were recognised in England, Scotland, and Wales. Post this date, CE-marked medical devices no longer apply in Great Britain.
- UKCA Compliance: Manufacturers are now required to comply with UK Conformity Assessed (UKCA) marking requirements, a critical step for market access in the UK.
- Draft Post-Market Surveillance Regulations: Proposed regulations for post-market surveillance are expected to be effective from 2024, impacting devices sold in England, Wales, Scotland, and Northern Ireland.
- Upcoming Statutory Instruments: Three key statutory instruments are anticipated – Transitional arrangements, Post-market Surveillance (PMS), and Future MDR. These will introduce new requirements and adjust existing ones for medical devices in the UK market.
Regulatory Framework for 2023
The MHRA’s 2023 framework includes:
- New Market Access Pathways: Designed to facilitate faster patient access to innovative medical devices.
- Software and AI Oversight: A framework for managing software as a medical device (SaMD) and artificial intelligence in medical devices.
- Amended IVD Regulations: Updated in vitro diagnostic regulations, including new device classification schemes and patient risk review processes.
- Sustainability in Device Manufacturing: Enhanced processes for re-using and re-manufacturing medical devices to reduce reliance on single-use devices.
Conclusion
The UK’s medical device regulatory landscape in 2023 marks a significant shift towards a more independent and localised framework, primarily influenced by the post-Brexit context. This includes the introduction of UKCA marking, revised regulations for medical devices, and a focus on innovative and sustainable medical technologies. Manufacturers and stakeholders in the UK medical market must be cognizant of these changes to ensure compliance and successful market access.
This overview provides a foundation for a blog post on UK medical market regulatory compliance in 2023, highlighting the key changes and their implications for manufacturers and other stakeholders.
- Medicines and Healthcare products Regulatory Agency (MHRA). “Regulating medical devices in the UK.” GOV.UK. [Online] Available: www.gov.uk. “Implementation of the Future Regulations.” GOV.UK. [Online] Available: www.gov.uk.
- “UKCA Compliance for Medical Devices: What You Need to Do by June 2023.” MDDI Online. [Online] Available: www.mddionline.com.
- “Countdown to June 2023 for UKCA compliance.” MedTech Intelligence. [Online] Available: medtechintelligence.com.
- “UK Releases Draft Post Market Surveillance Requirements for Medical Devices.” MedTech Intelligence. [Online] Available: medtechintelligence.com.
- “UK MHRA outlines key dates in 2023 for medical device regulatory changes.” Emergo by UL. [Online] Available: www.emergobyul.com.
- “Latest updates from UK regulators on post-Brexit changes to medical device and IVD regulatory requirements.” Emergo by UL. [Online] Available: www.emergobyul.com.
