Requirements relating to notified bodies in the European market

Last updated: 30 August 2023

Manufacturers who want to place their products on the European market should fulfill some legal requirements. Depending on the class risk of the product, manufacturers should employ an independent notified body to check and test these legal requirements. If requirements are being fulfilled, the notified body will issue an MDR certificate. Notified bodies in the European Union are companies or organizations that are designated the European Union member states to assess the conformity of certain products, based on the EU regulations such as medical devices or machinery. The importance of this blog article is to provide an overview of the requirements and role of the notified body in the European market.

In order to assess if the notified bodies fulfil their requirements, they were re-designated under the Medical Device Regulation (MDR) and In Vitro Medical Device Regulations (IVDR). The regulations currently are stricter than the previous medical regulations and have been included for impartiality, independence, staff expertise, and more detailed procedures which are followed when performing assessment works.

  1. Notified bodies should be designated by an EU member state and notified to the European Commission. In Germany, the German Federal institute for drugs and medical devices (BfArM) is responsible for designating notified bodies for medical devices. In France, the French Accreditation Committee is responsible for designating notified bodies. All designated notified bodies for Medical Devices can be found through the New Approach Notified Designated Organisations System (NANDO). For notified bodies to be designated, they must show proof that they are operating independently and with competence and that they will maintain this even after being designated.
  2. All notified bodies should have the required technical competence to perform conformity assessments of the products they are designated to assess. Any notified body in the medical environment should show qualifications and experience in the field of medical devices before they are designated. They are required to have the equipment, facilities, and procedures in place to carry out the assessments required for conformity assessments. In the UK, the notified body must have the United Kingdom Accreditation Service (UKAS) and meet all required technical competence of other relevant EU regulations.
  3. The notified bodies should show proof of being independent and impartial in their activities. In some countries, they are required to declare their independence from the manufacturer of the product being assessed and should not have any financial or other interests that might influence their decisions. It is also a requirement for them to show a plan of action in case there are any conflicts of interest that might arise while working with any of their clients.
  4. Notified bodies should have a quality management system that would comply with all the European Union regulations. In Italy, notified bodies comply with ISO 17065 for the certification of products. In Spain, notified bodies should have QMS that complies with SIO/IEC 17065. Even with the national QMS systems, all manufacturers should ensure that the notified body can issue ISO 13485 and ISO 9001. The system should cover all the aspects of the assessment activities including personnel, facilities, procedures, and records.
  5. Notified bodies are subject to regular surveillance by the designators. This will ensure that they meet the requirements for being designated. Surveillance might include random on-site visits, a review of the documentation, and assessments of the notified body’s performance. The Spanish Agency of Medicines and Medical Devices (AEMPs) is responsible for surveillance in Spain and Sweden notified bodies are subjected to regular surveillance by the Swedish medical products agency (MPA). 
  6. Notified bodies are required to report information to the relevant parties and EU member states. This entails, information about non-compliant products, adverse events, and any changes that might affect their status as designated. This will ensure that the authorities are well informed about any issues that might affect the safety and performance of medical devices on the European market.
  7. Notified bodies are required to review the technical documentation that is provided by the manufacturers of products. Technical documentation should demonstrate the conformity of products with regard to EU MDR. This is an important aspect for Medical device manufacturers as it determines compliance of the products on the market.
  8. Notified bodies are required to issue certificates to manufacturers of products that demonstrate conformity with the applicable EU regulations. The certification provided includes a CE mark.
  9. Notified bodies are required to carry out conformity assessments of medical device products. These conformity assessment services include carrying out tests, inspections, and certifications of the medical products to ensure that they are compliant with the regulations. These assessments must be carried out in accordance with the standards and procedures outlined by the EU MDR or EU IVDR
  10. Notified bodies are required to cooperate with the relevant authorities in the different member countries. This will include providing relevant information, responding to requests from these authorities, cooperating with surveillance, and any investigations. Support from notified bodies ensures that authorities have the information needed to determine if a product is safe to be on the market.

Manufacturers should understand that notified bodies play an important role in ensuring the safety and performance of medical devices or other products on the European market. While some processes can be done without the notified body, it is highly advisable to employ the services of a notified body within specific EU states. It is important to read about the notified body, the requirements, and others so that you do not have a conflict of interest with any organization you choose to work with. Notified bodies should also ensure they are compliant with the EU requirements so as to maintain the trust and confidence of consumers and regulators on the market.

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Read more about Dos and Don’ts for Medical Device Manufacturers Expanding into Europe

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