G/TBT/N/GBR/64  
26 July 2023  
(23-5094) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  UNITED KINGDOM  
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
Department of Health and Social Care: Medicines and Healthcare Products Regulatory 
Agency  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the n otification shall be indicated if different from above:   
UK TBT Enquiry Point  
Trade Policy Group  
Department for International Trade  
Old Admiralty Building  
London  
SW1A 2DY  
TBTEnquiriesUK@trade.gov.uk  
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  General 
Medical Devices , Active Implantable Medical Devices and  in vitro  Diagnostic Medical 
Devices, which are defined under regulation 2 of The Medi cal Devices Regulations 2002.  
5. Title, number of pages and language(s) of the notified document:  The Medical 
Devices (Post -market Surveillance Requirements) (Amendment) (Great Britain) 
Regulations 2023; (14 page(s), in English)  
6. Description of content:  This measure will amend the Medical Devices Regulations 2002 
as applicable in Great Britain. The amendments seek to introduce clearer, risk 
proportionate Post -market Surveillance (PMS) requirements. This will help to improve the 
ability of both the manufacturer and the MHRA to identify issues with Medical Devices 
placed onto the Great Britain market and where necessary, take appropriate action to 
safeguard public health.  
Some of the key changes include:  
a. Increased scope of devices that must comply with the new PMS requirements, this 
includes CE marked devices.  
b. Detail of what must be included as part of a PMS system, including the methods for 
collecting PMS data to support improved capturing of PMS data and harmonisation across 
manufacturers.  G/TBT/N/GBR/64  
 
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  c. Enhanced serious incident reporting obligations for manufacturers to support the 
detection of safety issues sooner.  
d. More stringent requirements for manufacturers to conduct periodic reviews of their 
PMS data including for implantable med ical devices. This aims to support manufacturers 
in earlier detection of trends/signals that may have an impact on the safety of a Medical 
Device.  
Improved coordination and collaboration between manufacturers, UK Approved Bodies 
and the MHRA to support reg ulatory oversight.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:   
The objective of this measure is to introduce clearer PMS requirements that are risk 
proportionate, with improved regulatory oversight. This is to en sure protection of human 
health and safety.  
Currently, under the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) 
once a medical device has been placed on the market, the manufacturer must continually 
monitor the performance of the medical dev ice. However, there are limited regulatory 
provisions surrounding Post Market Surveillance (PMS), which are high -level. 
Manufacturers are required to maintain a PMS system however, the detail surrounding 
how they conduct their PMS and vigilance obligations  are not covered by the current 
legislation but instead, are covered in guidance. Due to the lack of PMS requirements 
within the Medical Devices Regulations 2002, this has created inconsistencies in the way 
manufacturers placing devices on the GB market, p erform their PMS activities. This also 
impacts the quality of adverse incident data reported to the MHRA.  
Protection of human health or safety  
8. Relevant documents:   
The Medical Devices Regulations 2002 (legislation.gov.uk)  
A consultation on the future regulation of Medical Devices in the United Kingdom was held 
between Septem ber and November 2021. The Government Response to that Consultation 
on the future regulation of medical devices in the United Kingdom is found here: Chapter 
8 - Post-market Surveillance, Vigilance, Market Surveillance - GOV.UK (www.gov.uk)  
The Medical Devices (Post -market Surveillance Requirements) (Amendment) (Great 
Britain) Regulations 2023 (draft)  
9. Proposed date of adoption:  December 2023  
Proposed date of entry into force:  June 2024  
10. Final date for comments:  60 days from notification  
11. Texts available from:  National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
UK TBT Enquiry Point Trade Policy Group Department for International Trade Old 
Admiralty Building London SW1A 2DY TBTEnquiriesUK@trade.gov.uk  
https://members.wto.org/crnattachments/2023/TBT/GBR/23_11298_00_e.pdf