(Under forberedelse) Kommisjonens gjennomføringsforordning om fastsettelse av regler for gjennomføring av europaparlaments- og rådsforordning (2017) 745 med hensyn til Den europeiske databasen for medisinsk utstyr (Eudamed)
(In preparation) Commission Implementing Regulation laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the European Database on Medical Devices (Eudamed)
Utkast til forordning lagt fram av Kommmisjonen 25.5.2021 med tilbakemeldingsfrist 22.6.2021
BAKGRUNN (fra kommisjonsforordningen, engelsk utgave)
(1) Regulation (EU) 2017/745 requires the Commission to lay down the detailed arrangements necessary for the setting up and maintenance of the European database on medical devices (‘Eudamed’).
(2) Regulation (EU) 2017/746 of the European Parliament and of the Council requires the Commission to set up, maintain and manage Eudamed, in accordance with the conditions and detailed arrangements established by Regulation (EU) 2017/745.
(3) As provided for in Regulations (EU) 2017/745 and (EU) 2017/746, the Commission, competent authorities, authorities responsible for notified bodies, notified bodies, manufacturers, authorised representatives, importers, producers of systems and procedure packs and sponsors of clinical investigations and performance studies should have access to and use Eudamed for the purpose of complying with their obligations and carrying out their tasks under those Regulations. It is, therefore, necessary to provide for the accessibility of Eudamed via a restricted website. In addition, Eudamed should provide the public with adequate information about devices placed on the market, the corresponding certificates issued by notified bodies, the relevant economic operators and clinical investigations. It is, therefore, also necessary to make Eudamed accessible via a public website. Moreover, in order to allow for the exchange of data between Eudamed and national databases, it is necessary to make Eudamed accessible through machine-to-machine data exchange services.
(4) As regards natural and legal persons that need to be able to access Eudamed via the restricted website, it is necessary to specify the conditions and the procedure for granting such access.
(5) The Commission has established the European Medical Device Nomenclature (EMDN) as provided for in Regulations (EU) 2017/745 and (EU) 2017/746. The EMDN should therefore be made available in Eudamed free of charge and used for providing information on medical devices in Eudamed.
(6) In order to ensure that users of Eudamed receive the support needed when using the database, the Commission should provide them with timely technical and administrative assistance on Eudamed.
(7) In case of technical unavailability or malfunction of Eudamed, authorised users should still be able to fulfil their obligations. It is therefore necessary to specify alternative mechanisms to be used to exchange data in such events and to lay down contingency rules for such mechanisms.
(8) Rules on IT security set out in Commission Decision (EU, Euratom) 2017/46 apply to Eudamed. In order for Eudamed to function in a secure manner, protected against threats to the availability, integrity and confidentiality of its functions and data, additional security rules should be laid down.
(9) In order to mitigate risks and address potential fraudulent use of Eudamed, specific provisions on fraudulent user activity in Eudamed should be laid down.
(10) [The European Data Protection Supervisor was consulted in accordance with Article 42(1) of Regulation (EU) 2018/1725 of the European Parliament and of the Council [and delivered an opinion on (…)].]
(11) The measures provided for in this Regulation are in accordance with the opinion of the Committee on Medical Devices,
Helse- og omsorgsdepartementet