A notified body is an independent organisation designated by an EU country to assess the conformity of products before being placed on the market. Under EU MDR 2017/745, the notified body is also called a conformity assessment body.
A conformity assessment body (CAB) or a notified body is responsible for carrying out the conformity assessment procedure mentioned in the applicable Regulation.
What does a notified body do?
A notified body assesses whether the product conforms to the requirements set out in the legislation using a conformity assessment procedure. Some essential activities under the procedure include testing, certification, and inspection. A notified body is a third-party organisation that works for the benefit of manufacturers. The list of Notified bodies is updated on the NANDO website (New Approach Notified and Designated Organisations). A notified body also has a list of requirements that need to be fulfilled to carry out conformity procedures.
What is a conformity assessment?
Any legal manufacturer of a product can place their products if the product meets all the requirements. Before a product may be sold, it must undergo a conformity evaluation. The primary goal of the European Commission is to help ensure that dangerous or otherwise non-compliant items do not enter the EU market.
A conformity assessment is done
- Before a product is released on the market, its conformance is evaluated.
- To demonstrate compliance with all regulatory standards, which include testing, inspection, and certification.
- For each product, the applicable product regulation specifies the method of conformance.
In turn, a conformity assessment guarantees the following:
- The product about to be placed on the market meets all legal standards.
- The procedure ensures the confidence of consumers, public authorities, and manufacturers regarding the conformity of products.
How is the conformity procedure done?
Product legislation describes the conformity assessment method for each individual product. In the case of medical devices, EU MDR 2017/745 is the latest applicable legislation. Manufacturers may choose between different conformity assessment procedures, if applicable. The manufacturer may carry out the assessment. If the appropriate legislation requires it, a conformity assessment body is involved in the conformity assessment process.
At the end of the conformity assessment, a CE certificate is issued, which implies that the medical devices conform to the requirements set out in the applicable Regulation. This ensures that the manufacturer can freely market the device in the EU. The CE certificate and the device bear the CE marking adjacent to which the number of the notified body that issued the same is present.
Requirements to be met by Notified Bodies
Annex VII of EU MDR 2017/745 mentions the requirements for Notified bodies. Some general requirements like organisational structure, impartiality and confidentiality are mentioned. More specific requirements include the following:
- Maintenance of an appropriate QMS
The Quality Management System must be established such that management structure, documentation, policies and objectives are clear. The QMS must ensure that good documentation practices are followed. This includes control of documents and records, continuous reviews and frequent audits.
- Resource requirements
Notified bodies must be capable of carrying out all tasks assigned to them under the Regulation with the utmost professional integrity and competence in the specific field, whether done by notified bodies themselves or on their behalf and under their supervision. The personnel responsible for the tasks carried out by notified body must have suitable qualifications and adequate expertise.
- Process requirements
The notified body must have documented processes and sufficiently detailed procedures in place for the conduct of each conformity assessment procedure for which it is designated, including the individual steps from pre-application activities to decision-making and surveillance and considering, as necessary, the respective device specification.
Do all EU countries have a notified body?
No. Some countries do not have a notified body. The complete list of notified bodies under EU MDR is provided here. Some examples of notified bodies include TUV, SGS and BSI. These notified bodies do not have a presence in each European country, but the certification they provide is accepted elsewhere.
How do I choose the best-notified body for my devices?
While there is no one best-notified body, a couple of things should be considered when choosing one. Cost of the conformity assessment procedure, response, and geographic location of the notified body. Furthermore, choosing a notified body that also allows the MDSAP certification is considerable if the device is marketed to countries like the US, Canada, and so on.