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Medical Device Notified Bodies
Notified Bodies are entities designated/notified by the European Union member states to determine the conformity of certain products before being commercialized in the EU market.
They are independent certification institutions that are designated/notified by the EU member state’s Competent Authority to assess if a product or a system meets the applicable requirements laid out by the regulation for CE marking.
It should be noted that once a Notified Body is recognized by a Competent Authority, they will be recognized by all the other competent authorities to perform conformity assessment of products for the entire EU. So, a notified body will be notified by only one Competent Authority.
All bodies are not designated to be able to perform conformity assessments for medical devices. Instead, some Notified Bodies will be designated to do conformity assessment of other items such as toys, communication devices or construction products that have other regulation/directive.
A Notified Body must be independent of their clients or other interested parties. NB’s are commercial entities and that the manufacturers must pay them for their services. However, no Notified Body can be owned by a manufacturer or can be otherwise economically tied to make sure that the Notified Body maintains its independence.
The list of all the NB’s and the scope of their notifications are available on the NANDO website. One can check for NB’s and their applicable directive/regulation there. NB’s are assessed by the Competent Authority through communications and audits. They should routinely communicate with the competent authorities regarding:
- Assessments and their findings
- Issued, modified, suspended or withdrawn certificates
- Assessments performed supporting a certification decision
- Any significant changes in their organization, if any
MDR Notified Body
Medical device NB’s are conformity assessment bodies designated by the Competent Authority in accordance with the EU MDR 2017/745, Article 35.
It should be noted that the medical device NB is not like the FDA. It doesn’t have any enforcement power beyond issuing, maintaining, suspending or withdrawing CE certificates. Their main role is in getting a medical device in the EU market because the conformity assessment that they perform is a prerequisite for CE marking.
As per EU MDR, class Is, Im, Ir, IIa, IIb and III, a certificate from a Notified Body is compulsory for a manufacturer to be able to affix CE mark on their device, which is required for distribution and sale of such medical devices in the EU.
The primary task of a medical device Notified Body is to provide conformity assessment services according to the EU MDR, considering all the relevant guidance documents and harmonized standards. In order to perform the conformity assessment services, NB does whole a lot of activities than just showing up at the manufacturing facility.
Before performing the conformity assessment procedure, they confirm that the manufacturer has classified the medical device according to the classification rules in the MDR. To perform the conformity assessment services, an NB does activities such as:
- Certifying and auditing QMS
- Assessment of technical documentation
- Verifies products through sampling and testing
IVDR Notified Body
IVD NB’s play a major role in assisting manufacturers to place only safe and efficient IVD medical devices on the EU market. They are controlling the manufacturers by conducting conformity assessment activities and granting CE certificates to IVD medical devices in accordance with EU IVDR 2017/746, Article 32.
The main aspect of the role of IVD NB is to audit the QMS of the manufacturer and review the technical documentation of IVD A, B, C, and D classes. NB’s that have been notified under IVD can issue the IVDR conformity assessment certificates. These NB’s will issue EU QMS certificate, EU technical documentation assessment certificate, EU Production Quality Assurance Certificates and EU type-examination certificates depending on the conformity assessment activity selected.
The IVD NB’s will conduct surveillance audits annually as well as unannounced audits for the manufacturer and where applicable, for suppliers and subcontractors. Under the EU IVDR, the requirements for the NB’s to meet have increased substantially. The IVD bodies are subjected to a peer review every 3 years and due to this reason, it is expected to have the number of notified bodies under IVDR to be limited.
What Notified Bodies can’t do!
- The NBs cannot be a manufacturer, an EU Authorized Representative or a competitor of one of its clients.
- Duty of independence- All the NBs staffs must declare any potential conflict of interest to ensure no economic factors influence their decision to issue a CE certificate;
- NBs should have the duty of confidentiality, that is no disclosure of clients or their client’s products or technology to anyone but the Competent Authority, if the Competent Authority asks for it
- Duty of competence – Must carry out conformity assessment for which they are notified or designated by having the rightfully skilled staff, making sure they are trained properly etc.
Criteria for choosing a Notified Body
- The Notified body must be notified/designated to the directive or regulation of the product that you are using.
- Service of NBs must be checked as apt for your product.
- The expertise of the auditors is another factor for making an accurate assessment.
- The reputation of the Notified Body depending on their work ethics is another criterion.