Notified Bodies, Approved Bodies & Certification Bodies: What’s the Difference?

Notified Bodies

A Notified Body is an organisation designated and authorised by an EU member state to assess and verify the conformity of certain products, (medical devices and IVDs) with applicable EU regulations (EU MDR and IVDR) before they are placed on the market. The conformity assessment usually includes an
audit of the quality management system (QMS)and, depending on the device classification, and
review any associated technical documentation in line with requirements. The Notified Body may also perform an assessment of the Clinical Evaluation Report (CER) where needed, and whether General Safety and Performance requirements have been demonstrated. If a Notified Body is satisfied that a device submission conforms, to applicable legislation, they will issue a certificate of conformity, allowing the manufacturer to affix a CE mark to the device and take it to market. The Notified Body is then responsible for assessing the documentation on a regular basis.

Medical Devices belonging to the lowest risk classes, Class I are not subject to certification by a Notifief Body prior to CE marking, unless the device is sterile, a resuable surgical instrument or has a measuring funtion. Article 36 of the EU MDR states that in order to meet the requirements, a Notified Body shall have permanent availability of sufficient administrative, technical and scientific personnel, and personnel with relevant clinical expertise. Notified Bodies are required to make available and submit upon request all relevant documentation to the authority responsible to allow it to conduct its assessment, designation, notification, monitoring and surveillance activities and to facilitate the assessment outline in the chapter.

The European Commission published a list of such Notified Bodies that can undertake a third- party conformity assessment via their NANDO website and include DEKRA, TUV SUD, Eurofins and BSI.

Manufacturers of medical devices can decide which Notified Body they use, including in another country. Although it is the Notified Body that issues the certificate, the manufacturer is fully responsible for meeting the requirements for CE marking.

Approved Bodies

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 UK MDR 2002.
Manufacturers may apply to any UK Approved Body of their choice. Once the necessary certification is presented, products can be sold in England, Wales and Scotland and bare the UKCA mark. However, a CE marking continues to be needed for devices placed on the Northern Ireland market, and therefore manufacturers must use an EU-recognised Notified Body (as above), or a duly designated UK Notified Body to apply to the UKNI mark. The UK MDR 2002 covers active implantable medical devices (Part III), medical devices (Part II) and IVDs (Part IV). To ensure conformity to these standards, an Approved Body’s tasks will vary, again depending on the classification of the products and the assessment route chosen, based on the Annexes. The role of an Approved Body may include the following:

• Full assessment of the QMS including design; they will sample across a range of products and
  processes to ensure requirements are being met.
• Examination of the design including the full design dossier relating to each type of product.
• Examination of technical information relating to each type of product and carry out appropriate
  testing os a repesentative sample of production.
• Verification of every unit ot every batch of product before market access.
• Production and product quality assurance assessment of either the manufacturers quality system
  covering production QA or product QA, sampling across a range of products to ensure technical
  files are available.
• Unannounced audits of manufacturers to ensure procedures are in place.

Before appointing a UK Approved Body, the MHRA conducts a detailed assessment to ensure that the
organisation meets the relevant requirements before designating them for maximum 5 years. There are currenty 9 Approved Bodies for medical devices in the UK. You can find these listed on the MHRA website at: https://www.gov.uk/government/publications/medical-devices-uk-approved-bodies/uk approvedbodies-for-medical-devices

Certification vs Accreditation Bodies

Certification Bodies are independent organisations that assess and verify that a product, process or system complies with established standards or regulations. Accreditation Bodies are organisaions that
assess and formlly recognise the competence and impartiality of certification bodies or testing laboratories. Whilst the terms ‘accreditation’ and ‘certification’ are often used interchangeable, they are two closely related but distinct steps on the QA/RA ladder.

Certification Bodies are responsible for evaluating whether a particular product, process or system meets relevant quality and safety standards (such as ISO 13485:2016) or specific regulations. Certification bodies may conduct audits, inspections and testing to determine if the required standards are met. Once they are satisfied with the device’s complaince, they issue a certification or conformity assessment certificate, for example.

Accreditation Bodies are responsible for evaluating the processes and capabilities of certification bodies that assess and certify organisations. They ensure that certification bodies are qualified to perform their certification services and that they adhere to international standards and best practice. The accreditaton bodies assure stakeholders that the certification body‘s assessment are reliable. The accreditation body typical follows international standards, respectively.

Examples of some well known Certification Bodies include BSI Group, TÜV SÜD, SGS, UL
Solutions, Intertek and DEKRA. Examples of Accreditaton Bodies include ANSI National Accreditation Board (ANAB), Inited Kingdom Accreditation Service (UKAS), Deutsche Akkreditierungsstelle (DAkkS), National Association of Testing Authorities Australia (NATA) and INMETRO Brazil.

Both certification bodies and accreditation bodies play crucial roles in the quality assurance and
regulatory compliance of medical devices.

If you would like any further information on how Apotech can assist you with liasing with Notified, Approved and Certification Bodies then please get in touch!

www.apotechconsulting.com
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