A manufacturer is only allowed to market a medical device in Europe if it fulfils certain legal requirements. The term medical devices also includes in vitro diagnostics. Depending on the risks associated with a medical device, an independent notified body has to be involved to check and/or test whether these legal requirements are fulfilled. If the requirements are being fulfilled, the notified body will issue a certificate. After that the manufacturer is allowed to market the medical device.
Notified bodies are subject to stringent requirements. The organisation and individual staff must be completely independent and impartial. In addition to that they must have the competence e and experience necessary to perform the work. The Health and Youth Care Inspectorate (IGJ) is responsible for monitoring this.
Notified bodies are designated by the member state where the notified body is located and perform work for the entire European market. This means that medical devices which have been certified by a Dutch notified body are allowed to be marketed in all EU countries. The European NANDO database contains the details of all notified bodies designated by the member states.
In the Netherlands 4 notified bodies have now been designated for the certification of medical devices:
- BSI Group The Netherlands B.V.
- DEKRA Certification B.V.
- Kiwa Dare B.V.
- Scarlet NB B.V.
The tasks of a notified body
A notified body assesses whether medical devices with an average or high risk fulfil the legal requirements before a product can be sold on the European market. If a medical device is being marketed, the notified body also periodically checks whether the manufacturer fulfils the legal requirements.
The tasks performed by a notified body:
- Assessing whether the technical dossiers of medical devices fulfil the legal requirements.
- Performing planned audits at manufacturers to:
- Assess whether medical devices are designed and produced responsibly in order to comply with the statutory requirements.
- Check whether manufacturers carefully monitor the safety of their product in the market and take action as necessary to keep patients safe.
- Performing unannounced audits at manufacturers to assess whether the production process is properly controlled and whether products fulfil the statutory requirements.
- Performing audits at the manufacturer's most important subcontractors which help to ensure a safe end products.
Notified bodies under the MDR and IVDR
The European MDR and IVDR regulations impose stricter requirements on notified bodies. In order to assess whether notified bodies fulfil these stricter requirements, they will be re-designated under the MDR and the IVDR. Among other things, stricter requirements have been included for impartiality, independence, staff expertise and more detailed procedures which have to be followed when performing assessment work.
The Minister of Health, Welfare and Sport (VWS) will designate the Dutch notified bodies for the MDR and IVDR. The first re-assessment of the notified body will take place 5 years after designation, after which the notified body will be re-assessed every 5 years.
The designation and re-assessments will be carried out by a joint assessment team made up of officials from the Health and Youth Care Inspectorate, members of a European assessment team from the European Commission and experts from other member states. The European Commission and the European Medical Device Coordination Group (MDCG) are closely involved in the designation process and must both have issued a positive opinion before a Dutch notified body can be designated by the Minister of VWS.
IGJ monitoring
After the designation, the IGJ monitors the Dutch notified bodies. This monitoring consists of:
- regular inspection visits;
- the assessment of certification dossiers;
- assessments on location of notified body audits at manufacturers;
- investigations of non-conformity reporting on the method of working or decisions taken by a notified body.
The IGJ monitoring obligations are described in the MDR and IVDR and are the same for all member states. Every year member states will draw up a monitoring plan for each notified body which will be assessed by the European Commission and the MDCG. The member states are required to report to the European Commission every year.
The European Commission's NANDO database provides an up-to-date overview of all designated notified bodies in Europe for the Medical Devices Regulation and the In Vitro Diagnostic Devices Regulation.
Validity of previous certificates
The MDR came into force on 26 May 2021, repealing the MDD and AIMDD Directives. Due to transitional provisions, certificates issued under the MDD/AIMDD that were issued by notified bodies before 26 May 2021 will remain valid. The period of validity is stated on the certificate. See ‘MDR/IVDR transitional periods’ below for information on how long certificates remain valid under the transitional provisions. The notified body that issued the certificate remains responsible for supervising the manufacturer during the transitional period.
Under the transitional provisions, the manufacturer must already comply with a number of new requirements under the MDR (Article 120) and the manufacturer may not make any significant changes to the product. If the manufacturer does make significant changes, the medical device must comply with the requirements of the MDR. The manufacturer must also request an MDR assessment from a notified body.
The IVDR came into force on 26 May 2022, replacing the IVDD Directive.
Different validity periods apply to IVDs that already held a certificate from a notified body under the IVDD. The IVDR establishes far more requirements, which creates more work for manufacturers and notified bodies. That is why the European Commission has decided that more time will be granted in these cases to ensure that IVDs comply with the new requirements. The validity period of the IVDD certificate depends on the risk classification of the IVD under the IVDR.
A key condition to this extension is that no significant change may be made to the IVD itself or to how it is used. Should this nevertheless be required, then the IVD must be assessed and certified under the IVDR. The manufacturer may only make the modified IVD available on the market once an IVDR certificate has been issued.
From 26 May 2022, however, manufacturers must comply with a number of new requirements under the IVDR for all IVDs, including in relation to post-market surveillance, vigilance, registration of economic operators and IVD products. The notified body that issued the certificate will remain the authority responsible for the appropriate surveillance of the manufacturer during the transitional period. This appears in Article 110.3 of the IVDR.
The transitional provisions give manufacturers and notified bodies more time to ensure that IVDs comply with the requirements of the IVDR. Nevertheless, it is crucial that manufacturers should already make preparations to have their IVDs certified at this stage. If they were to wait, there is a risk of there being too little capacity available at the notified bodies at the end of the transition period. As a result, an IVD may not be certified in time, meaning that the manufacturer would not be able to make it available on the market.