Approved bodies for medical devices
Updated 1 July 2023
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Overview
The government has extended acceptance of CE marked medical devices in Great Britain. For more detail on this see the implementation update on work towards a strengthened future medical devices regime.
The Medicines and Healthcare products Regulatory Agency (MHRA) is the designating and competent authority in the UK.
An approved body is an organisation that has been designated by the MHRA to assess whether manufacturers and their medical devices meet the requirements set out in the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).
Manufacturers can apply to any UK approved body and once they have the necessary certification their products can be sold anywhere in Great Britain (England, Wales and Scotland). Following an appropriate assessment, the approved body will issue relevant certification allowing manufacturers to place UKCA marking on their products and place them on the market in Great Britain.
Although the UKCA mark will be available for use in Great Britain from 1 January 2021, CE marking will continue to be needed for devices placed on the Northern Ireland market and EU rules will need to be met. CE-marked medical devices continue to be accepted on the Great Britain market with the deadline for acceptance depending on the type of device and the legislation it complies with. The latest of these deadlines is 30 June 2030. For more detail see the guidance here.
From 1 January 2021, to place a CE mark on a medical device for circulation in both Northern Ireland and the EU, manufacturers must use an EU-recognised notified body to undertake any mandatory third-party conformity assessment. The results of conformity assessments carried out by UK notified bodies will not be recognised within the EU.
Duly designated UK Notified Bodies will be able to conduct conformity assessments for the purposes of the Northern Ireland market alone. For these products, in addition to the CE marking, device manufacturers will also need to apply the UKNI marking. These products cannot circulate on the EU market.
The UK MDR 2002 covers the following:
- active implantable medical devices, covering all powered implants (Part III of the UK MDR 2002)
- medical devices, covering most other medical devices (Part II of the UK MDR 2002)
- in vitro diagnostic medical devices, covering any medical device which is intended for in vitro testing. (Part IV of the UK MDR 2002)
Role of the approved body
An approved body’s tasks will vary depending on the classification of the products concerned and the conformity assessment route a manufacturer has chosen. The conformity assessment procedures will be based on the Annexes as defined within the Medical Device Regulations 2002 (as modified by Schedule 2A to the Medical Devices Regulations 2002).
Typical activities that can be undertaken by an approved body include:
- full quality assurance: the approved body will carry out an assessment of the manufacturer’s quality system, including design; they will sample across the range of products and processes to ensure that the requirements are being met
- examination of the design: the approved body will assess the full design dossier relating to each type of product to ensure that they meet the requirements
- type examination: the approved body will assess the full technical information relating to each type of product and carry out appropriate testing of a representative sample of production to ensure that it meets the requirements
- verification: the approved body will either test every unit or every batch of product to ensure that they are meeting the requirements before the manufacturer can place them onto the market
- production and product quality assurance: the approved body will carry out an assessment of either the manufacturer’s quality system covering production and inspection (production QA) or final inspection (product QA); they will sample across the range of products to ensure that relevant technical files are available as well as ensuring that the relevant processes being undertaken meet the requirements
- conduct unannounced audits of manufacturers: approved bodies will conduct unannounced audits of manufacturers to ensure manufacturers have procedures in place to meet UK requirements
Existing CE certificates where there is a change or update
CE certificates issued previously by UK Notified Bodies before 1 January 2021 will remain valid for the GB Market. If there is a change or update, the relevant UK approved body will need to issue a new UKCA certificate to replace the CE certificate.
UK approved bodies
Become an approved body
If you want to become an approved body you should email info@mhra.gov.uk.
After successful designation, the MHRA monitors UK approved bodies by regular audits and by witnessing their compliance assessment of manufacturers. Both designation and monitoring are subject to fees.
Contact the MHRA about a UK Approved Body
The MHRA has a dedicated regulatory team who fulfil the MHRA’s obligations regarding the designation and monitoring of UK approved bodies.
If you have an enquiry about a UK approved body you should email info@mhra.gov.uk.
Enquiries relating to Notified Bodies based in Europe should be directed in the first instance to the Designating Authority of the European Member state within which the Notified Body is based.
Withdrawal of UK Approved Body services
Background
The scope of designation of a UK approved body (which tasks it does) may change at any time. In certain situations, this can happen at short notice and in these cases, the validity of the UKCA or CE UKNI certificates previously issued may be affected.
There are no specific provisions under current legislation regarding the ongoing validity of UKCA or CE UKNI certificates in such scenarios. Therefore, the MHRA has implemented a process so that manufacturers can keep placing products on the UK market while they transfer to a new UK approved body.
Who this process is for
Manufacturers based in the UK, or those outside the UK with a UK Responsible Person who place products on the UK market with a valid UKCA or CE UKNI certificate under the UK MDR 2002, and who have been affected by closure or scope reduction of their UK approved body.
Support provided by the MHRA
If you are eligible, the MHRA may offer a grace period where you can continue to place products on the UK market until you find a new UK approved body. The MHRA’s decision whether or not to support a manufacturer is made on a case-by-case basis. The offer is dependent on you meeting a number of conditions. This includes regular updates from you to enable the MHRA to monitor progress made in transferring to a new UK approved body and status of UKCA or CE UKNI certification. During the grace period if you fail to keep to the conditions, or if there is evidence of the devices not meeting the relevant safety requirements, we will withdraw the permission. If you gain applicable certification before the end of the grace period, the MHRA’s support will end, and you will no longer fall under the MHRA’s oversight.
You can contact the MHRA at info@mhra.gov.uk for further information.
Please note that this process does not replace the activities of a UK approved body and it is not applicable to manufacturers who do not place products on the UK market. In addition, this process does not cover the withdrawal of an EU notified body. UK based manufacturers, or their UK Responsible Person, who place devices on the UK market, who have been newly affected by the withdrawal of EU notified body services and wish to continue to sell products in the UK should review the guidance on exceptional use authorisations.
Previous Withdrawal of services of UK Notified Bodies (prior to December 2020)
The MHRA will continue to provide transitional support to UK manufacturers and/or Authorised Representatives affected by the closure of a UK Notified Body prior to December 2020. This support is solely for the Great Britain market (England, Wales and Scotland).