MHRA registration for maxillofacial laboratory services 2021
Outline
Recently there have been UK and European government led proposals to change legislation that controls the manufacture and supply of medical devices.
During the latter half of 2020 UK government made changes to previously agreed post-BREXIT market conditions with the result that European Regulations, such as EU Medical device regulation 2017/745, will now not come into force.1
As a consequence, and to cover any statutory interim period, on 31 December 2020 MHRA published guidance that highlighted the need for UK medical device manufacturers to comply with current legislation.2
However while existing UK regulation encompasses the manufacture of medical devices, the legislation is reliant on the Medical Devices Directive (MDD 93/42/EEC, 14 June 1993) supported by legal enforcement as defined by Consumer and Sale of Goods Acts. This multi-layered regulatory pathway has now been viewed as unsafe and ineffective by both European and UK governments.3
To this end, on 08 May 2021, a new piece of legislation was brought into force within the UK; the “Medicines and Medical Devices Act (2021)”. This statute was introduced to enable UK based medical device manufacturers to operate within the post-BREXIT European markets.
On 05 July 2021 it was announced that, following the introduction of the “Medicines and Medical Devices Act (2021), and as a part of a 3 year implementation plan, MHRA will introduce a new legislative framework to control the manufacture and supply of medical devices within the UK.4
Comment
There is little detail contained within the Medicines and Medical Devices Act (2021) that is relevant to cranio-maxillofacial prosthetics or custom-made medical devices. To this end there will most likely be no immediate impact for IMPT members.
However, it is clear that the recent Medicines and Medical Devices Act (2021) was introduced to enable an overhaul of UK legislative framework. Now vested with greater legal flexibility, UK government will be able to introduce new laws via secondary legislation and provide MHRA with additional powers of enforcement.5
Accordingly, we should assume that further regulation and guidance will be forthcoming from MHRA within the next 3 years and it is likely that these proposed changes to UK legislation will ultimately effect our manufacturing practice.
Should previously accepted European legislation, such as EU 2017/745, be used as a template for future regulation by MHRA, proposed guidance will most likely formalise and encompass regulatory elements such as;
- quality management systems
- transfer between legal entities
- risk management strategy
- device risk assessment
- inspection of manufacturing site
- post-market clinical follow up
- requirements for health-institutions
- periodic safety update reporting
- unique device identification.
However, during the current interim period, guidance published by MHRA in December 2020 simply reaffirms that, at the present time and if certain conditions are met, manufacturers of custom-made medical devices must register their activities with MHRA, and so are directed to;
- follow requirements of Part II of the UK MDR 2002 for custom-made devices 6
- observe MHRA guidelines specific to custom-made devices 7
- record the class of devices registered using a Global Medical Devices Nomenclature (GMDN) code and term to describe each device 8
- pay a £100 fee to register up to 100 products (device types). 8
Current MHRA guidance regarding the In-house manufacture of medical devices, that includes “transfer between hospitals”, has also been updated.9
Recommendation
During this regulatory interim period; with consideration for the above and in the best interests of patient care, IMPT Council recommends that all UK maxillofacial laboratory services register their manufacturing activities with MHRA.
The current registration process is straightforward, inexpensive and, ahead of further regulations coming into force within the UK, will provide each maxillofacial laboratory service with a graduated pathway to legislative compliance.
While there is current guidance available from MHRA for device classification, it is intended that examples of relevant GMDN coding, relevant for custom-made cranio-maxillofacial medical devices, will also be provided on the IMPT website.
References
- IMPT website, News item: Medical Device Regulations, 08 October 2020
- https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market
- IMPT website, News item: MDR Update, 01 July 2021
- https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/999071/MHRA_Delivery_Plan_21-23_Final_210618.pdf
- https://www.gov.uk/government/publications/the-medicines-and-healthcare-products-regulatory-agency-delivery-plan-2021-2023/medicines-and-healthcare-products-regulatory-agency-delivery-plan-2021-2023
- https://www.legislation.gov.uk/uksi/2002/618/regulation/15/made
- https://www.gov.uk/government/publications/custom-made-medical-devices
- https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market#who-must-register
- https://www.gov.uk/government/publications/in-house-manufacture-of-medical-devices/in-house-manufacture-of-medical-devices
