Implementing regulation 2021/2078 - Rules for the application of Regulation 2017/745 as regards the European Database on Medical Devices (Eudamed) - Main contents
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official title
Commission Implementing Regulation (EU) 2021/2078 of 26 November 2021 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)| Legal instrument | Implementing regulation |
|---|---|
| Number legal act | Implementing regulation 2021/2078 |
| Regdoc number | C(2021)8447 |
| CELEX number i | 32021R2078 |
| Document | 26-11-2021; Date of adoption |
|---|---|
| Publication in Official Journal | 29-11-2021; OJ L 426 p. 9-15 |
| Effect | 19-12-2021; Entry into force Date pub. +20 See Art 12 |
| End of validity | 31-12-9999 |
29.11.2021 |
EN |
Official Journal of the European Union |
L 426/9 |
COMMISSION IMPLEMENTING REGULATION (EU) 2021/2078
of 26 November 2021
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)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (1), in particular Article 33(8) thereof:
Whereas:
(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 (2) 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) No 2017/746, the Commission, competent authorities, authorities responsible for notified bodies, notified bodies, manufacturers, authorised representatives, importers, natural or legal persons referred to in Article 22(1) of Regulation (EU) 2017/745 (system or procedure pack producers) 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) No 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 (3) 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... |
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