According to the MDR requirements, Notified Bodies (NB) should be designated to maintain operations connected with the registration process and perform other supervisory actions. In the course of these medical device regulations, the Spanish regulating authority, the Agency of Medicines and Medical Products (AEMPS) has announced their intent to become a designated NB.

The Role of Notified Bodies

NBs were introduced by the EU`s medical device regulations (MDR) to perform the assessment of marketing applications filed by medical device manufacturers. According to applicable regulations, they must provide conformity assessment services acting in connection with Notified Authorities – state regulatory authorities empowered to maintain supervision in the sphere of healthcare in general, particularly medical devices. The performance of NBs should be based on the following principles:

  • Transparency, independency and impartiality
  • Professional insurance
  • Employment of high-qualified and experienced specialists
  • Data protection and confidentiality
  • Informational exchange with other regulatory authorities

According to the MDR, medical device manufacturers going to submit marketing applications could choose any from the list of designated NBs. Each NB acts independently, conducting assessment procedures based on the applicable regulations and standards. As usual, the process includes an examination of both product documentation and the quality system used by the manufacturer. The main goal of NB institute implementation is to reduce the operational flow faced by regulatory authority to improve the quality of assessment while simplifying the procedure and reducing related costs.

The AEMPS Designation Process

AEMPS will be able to operate as a NB by the end of 2020. Special authorizing bodies are conducting the assessment of AEMPS to ensure all requirements necessary for Notified Bodies are applied. Due to the numerous requirements, listed above, the designation procedures take time. The organization applying for NB designation should employ all technical and organizational measures necessary to perform conformity assessment procedures in accordance with the regulations and standards.

The timely designation of NBs is important to maintain the regulatory process. After 2020, all medical device manufacturers will have to submit applications exclusively to the NB (AEMPS). At the same time, it would be also necessary to review already existing permits that would expire until 2020. In the case of any failure of the NB to perform their obligations in the healthcare sphere, they may face a shortage of medical devices. It would be allowed to distribute already produced medical devices, but all new devices would need to pass conformity assessment procedures in accordance with the new regulatory requirements. Currently there are only two entities already designated as NBs, including London-based BSI and German TUV SUD.