Guidance

Notified bodies for medical devices

Updated 22 June 2017

Overview

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

Subcontractors

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

UK notified bodies

EU notified bodies

Become a notified body

If you want to become a notified body you should contact Dhruti Patel by emailing dhruti.patel@mhra.gsi.gov.uk or calling 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 contact Dhruti Patel by emailing Dhruti.patel@mhra.gsi.gov.uk or calling 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.

Guidance

Requirements for UK notified bodies

Guidance for notified bodies on the regulation of IVDs for self-testing

Notified Body Operations Group (NBOG): Designating Authorities Handbook