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This publication is available at https://www.gov.uk/government/publications/notified-bodies-for-medical-devices/notified-bodies-for-medical-devices
A notified body is an organisation that has been designated by an EU member state (the designating authority) to assess whether manufacturers and their medical devices meet the requirements set out in legislation.
The Medicines and Healthcare products Regulatory Agency (MHRA) is the designating and competent authority in the UK.
Manufacturers can apply to any notified body in the EU and once they have the necessary certification their products can be sold anywhere in the EU. Following an appropriate assessment, the notified body will issue relevant certification allowing manufacturers to put CE-marks on their products and put them on the market in the EU.
There are 3 pieces of EU legislation which cover medical devices.
90/385/EEC Active implantable medical devices covers all powered implants.
93/42/EEC Medical devices covers most other medical devices.
98/79/EC In vitro diagnostic medical devices covers any medical device which is intended for in vitro testing.
Role of the notified body
A notified 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 can be found in the annexes of each of the 3 pieces of legislation.
Typical activities that can be undertaken by a notified body include:
- full quality assurance: the notified 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 notified body will assess the full design dossier relating to each type of product to ensure that they meet the requirements
- type examination: the notified 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 notified 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 notified 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 - it’s now mandatory for notified bodies to conduct unannounced audits of manufacturers according to Annex III of the Commission Recommendation (2013/473/EU) of 24 September 2013
A notified body will not necessarily have to carry out every part of the testing and/or auditing with its own staff or facilities. Some aspects, such as testing, auditing or clinical reviews, may be undertaken by subcontractors.
If work is subcontracted out, the notified body keeps final and overall responsibility and is also responsible for the competence of its subcontractors.
Approved notified bodies
Become a notified body
If you want to become a notified body you should contact email email@example.com or call 020 3080 7194.
After successful designation, MHRA monitors UK notified bodies by regular audits and by witnessing their compliance assessment of manufacturers. Both designation and monitoring is subject to fees.
Contact the MHRA about a UK Notified Body
MHRA has a dedicated regulatory team who fulfil MHRA’s obligations regarding the designation and monitoring of UK Notified Bodies.
If you have an enquiry about a UK Notified Body you should email firstname.lastname@example.org or call 0203 080 7194.
Enquiries relating to Notified Bodies based elsewhere 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. A full list of contacts for the EU member states can be found on the European Commission website at the following link.
Withdrawal of notified body services
The scope of designation of a notified 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 CE certificates previously issued may be affected.
There are no specific provisions under current legislation regarding the ongoing validity of CE certificates in such a scenario. Therefore, MHRA has implemented a process so that manufacturers can keep placing products on the EU market while they transfer to a new notified body. This process is aligned to guidance provided by:
- the European Commission (The ‘Blue Guide’, 2016/C 272/01)
- the Notified Body Operations Group’s (NBOG) Best Practice Guide on ‘Changes of Notified Body’
- guideline agreed upon at the European Meeting of Competent Authorities (CAMD).
Who is this process for?
Manufacturers based in the UK, or those outside the UK with an authorised representative based in the UK, affected by closure or scope reduction of their notified body with a valid CE certificate under Directives 93/42/EC, 98/79/EC and 90/385/EC.
Support provided by MHRA
If you are eligible, MHRA may offer a grace period where you can continue to place products on the EU market until you find a new notified body. 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 MHRA to monitor progress made in transferring to a new notified body and status of CE 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 CE certification before the end of the grace period, MHRA’s support will end, and you will no longer fall under MHRA’s oversight.
You can contact MHRA at email@example.com for further information.
Please note that this process does not replace the activities of a notified body and it is not applicable to manufacturers who can’t transition their certificates from Directives 93/42/EC, 98/79/EC and 90/385/EC to Regulations 2017/745 and 2017/246.