November 2021: European Database on Medical Devices (Eudamed) Update

European Commission updated regarding, 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)posted in the Official Journal of the European Union, on November 30, 2021:

The commission presents eleven articles that explain in detail regarding setting up, accessibility, functional rules, maintaining and managing Eudamed along with different definitions that apply to this regulation. It is mentioned in Article 2 that Eudamed would provide access to authorized users via ‘a restricted website’ and for non-identified users via ‘a public website’.

According to Article 3, to gain access to the restricted website a natural person needs to create an account on the Commission authentication service from where the Commission would register the competent authorities and the authorities responsible for the notified bodies and grant access to the first natural person on their behalf. For other entities to be registered in Eudamed a natural person acting on behalf of the prospective actor shall submit an actor registration request, via the restricted website which would then be approved by the national competent authority.

It is also mentioned in Article 9, that the Commission would provide a website for testing and training to the respective actor website. It would be mandatory for the actor to make at least one successful attempt of data submission using the testing website. The Commission also clarified that the data entered in the testing website would be considered fictitious and would not be available for the public. Concerned actors would be notified in advance via Eudamed of any changes and the period of availability on the testing website.

According to article 12, this regulation will come into force on the twentieth day following its publication in the Official Journal of the European Union and would directly be applicable in all Member States.

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