Overview
The Medicines and Health Products Regulatory Agency (MHRA) is the designating and competent authority in the United Kingdom.
An approved body is an organization that has been appointed 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) (United Kingdom MDR 2002).
Manufacturers can go to any approved body in the UK and once they have the necessary certification their products can be sold anywhere in Great Britain (England, Wales and Scotland) . After a proper assessment, the approved body will issue the appropriate certification allowing manufacturers to affix the UKCA mark on their products and market them in Great Britain.
Although the UKCA mark will be available for use in Great Britain from January 1, 2021, CE marking will continue to be required for devices placed on the market in Northern Ireland and EU rules will need to be respected. CE marked devices will also be accepted on the UK market until June 30, 2023.
From 1 January 2021, in order to affix a CE mark to a medical device intended for circulation in Northern Ireland and the EU, manufacturers must use a notified body recognized by the EU to undertake any conformity assessment by a mandatory third party. The results of conformity assessments carried out by UK notified bodies will not be recognized within the EU.
Duly designated UK Notified Bodies may carry out conformity assessments for the purposes of the Northern Ireland market only. For these products, in addition to the CE mark, device manufacturers will also have to apply the UKNI mark. These products cannot circulate on the EU market.
Great Britain MDR 2002 covers the following:
- active implantable medical devices, covering all motorized implants (UK Part III MDR 2002)
- medical devices, covering most other medical devices (UK Part II MDR 2002)
- in vitro diagnostic medical devices, covering any medical device intended for in vitro tests. (UK Part IV MDR 2002)
Role of the accredited body
The tasks of an approved body will vary depending on the classification of the products concerned and the conformity assessment route chosen by the manufacturer. The conformity assessment procedures will be based on the annexes as defined in the Medical Device Regulations 2002 (as amended by Annex 2A of the Medical Devices Regulations 2002).
Typical activities that can be undertaken by an accredited body include:
- full quality assurance: the approved body will carry out an assessment of the manufacturer’s quality system, including the design; they will sample the entire range of products and processes to ensure requirements are met
- design examination: the approved body will assess the complete design dossier for each type of product to ensure that it meets the requirements
- type examination: the approved body will assess all technical information relating to each type of product and carry out appropriate tests on a representative sample of production to ensure that it meets the requirements
- verification: the approved body will test each unit or batch of products to ensure that they meet the requirements before the manufacturer can place them on the market
- production and product quality assurance: the approved body will conduct a manufacturer’s quality system assessment covering production and inspection (production QA) or final inspection (product QA); they will sample the entire product line to ensure that the relevant technical files are available and to ensure that the relevant processes undertaken meet the requirements
- conduct unannounced audits of manufacturers: Approved bodies will conduct unannounced audits of manufacturers to ensure that manufacturers have procedures in place to meet UK requirements
Existing CE certificates in case of modification or update
CE certificates previously issued by UK Notified Bodies before January 1, 2021 will remain valid for the UK market. In the event of a change or update, the relevant UK approved body will have to issue a new UKCA certificate to replace the CE certificate.
Approved bodies in the UK
Approved bodies in the UK
Become an approved organization
If you want to become an approved body, you must send an email to [email protected]
After successful designation, the MHRA monitors approved bodies in the UK through regular audits and assisting in the conformity assessment of manufacturers. Appointment and supervision are subject to fees.
Contact the MHRA about an accredited body in the UK
the MHRA has a dedicated regulatory team that fulfills the MHRAthe obligations concerning the designation and supervision of accredited bodies in the United Kingdom.
If you have a question regarding an approved body in the UK, you should send an email to [email protected]
Requests for notified bodies based in Europe should be addressed first to the designating authority of the European Member State in which the notified body is based.
Withdrawal from the services of an approved body in the United Kingdom
Context
The scope of designation of an approved body in the UK (what tasks it performs) may change at any time. In some situations this may happen at short notice and in these cases the validity of previously issued UKCA or CE UKNI certificates may be affected.
There are no specific provisions in current legislation regarding the continued validity of UKCA or CE UKNI certificates in such scenarios. Therefore, the MHRA has a process in place for manufacturers to continue bringing products to the UK market while they transfer to a new approved body in the UK.
Who is this process for?
Manufacturers based in the UK, or those outside the UK with a UK responsible person who place products in the UK market with a valid UKCA or CE UKNI certificate under UK MDR 2002, and who were affected by the closure or downsizing of their UK approved body.
Assistance provided by the MHRA
If you are eligible, the MHRA may offer a grace period during which you can continue to place products in the UK market until you find a new approved body in the UK. the MHRAThe decision whether or not to support a manufacturer is made on a case-by-case basis. The offer depends on the fulfillment of a number of conditions. This includes regular updates from you to activate the MHRA to track progress in moving to a new UK approved body and UKCA or CE UKNI certification status. During the grace period, if you do not comply with the conditions or if there is evidence that the devices do not meet the applicable security requirements, we will revoke the authorization. If you obtain the applicable certification before the end of the grace period, the MHRAsupport ends and you will no longer fall under the MHRAoversight.
You can contact the MHRA at [email protected] for more information.
Please note that this process does not replace the activities of an approved body in the UK and does not apply to manufacturers who do not place products on the UK market. In addition, this process does not cover the withdrawal of a notified body from the EU. UK-based manufacturers, or their responsible person in the UK, who place devices on the UK market, who have been newly affected by the withdrawal of EU Notified Bodies services and wish to continue selling products in the UK should review the guidance on exceptional use permits.
Previous withdrawal from UK Notified Body services (before December 2020)
the MHRA will continue to provide transitional support to UK manufacturers and / or authorized representatives affected by the closure of a UK Notified Body before December 2020. This support is only intended for the UK market (England, Wales and Scotland).
Orientation
Requirements for accredited bodies in the UK
Designating Authority Manual
