Implementing regulation 2022/944 - Rules for the application of Regulation 2017/746 as regards the tasks of and criteria for EU reference laboratories in the field of in vitro diagnostic medical devices - Main contents
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Commission Implementing Regulation (EU) 2022/944 of 17 June 2022 laying down rules for the application of Regulation (EU) 2017/746 of the European Parliament and of the Council as regards the tasks of and criteria for European Union reference laboratories in the field of in vitro diagnostic medical devices| Legal instrument | Implementing regulation |
|---|---|
| Number legal act | Implementing regulation 2022/944 |
| Regdoc number | C(2022)4311 |
| CELEX number i | 32022R0944 |
| Document | 17-06-2022; Date of adoption |
|---|---|
| Publication in Official Journal | 20-06-2022; OJ L 164 p. 7-19 |
| Effect | 10-07-2022; Entry into force Date pub. +20 See Art 19 |
| End of validity | 31-12-9999 |
20.6.2022 |
EN |
Official Journal of the European Union |
L 164/7 |
COMMISSION IMPLEMENTING REGULATION (EU) 2022/944
of 17 June 2022
laying down rules for the application of Regulation (EU) 2017/746 of the European Parliament and of the Council as regards the tasks of and criteria for European Union reference laboratories in the field of in vitro diagnostic medical devices
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (1), and in particular Article 100(8), point (a), thereof,
Whereas:
(1) |
Regulation (EU) 2017/746 lays down rules on European Union reference laboratories (the ‘EU reference laboratories’). |
(2) |
The criteria that the EU reference laboratories are to satisfy are set out in Article 100(4) of Regulation (EU) 2017/746. The Commission is to lay down detailed rules in order to ensure compliance with those criteria. |
(3) |
In order to ensure compliance with the criterion regarding adequate and appropriately qualified staff laid down in Article 100(4), point (a), of Regulation (EU) 2017/746, the EU reference laboratories should have a sufficient number of technical and scientific staff. Minimum levels of education and professional experience for that staff and the EU reference laboratory director should be specified. In order to ensure that the appropriate qualifications, knowledge and experience of the staff are maintained, the EU reference laboratories should be required to put in place a continuous training and education programme. |
(4) |
In order to ensure compliance with the criterion regarding equipment and reference material laid down in Article 100(4), point (b), of Regulation (EU) 2017/746, the EU reference laboratories should be required to keep documentation demonstrating that they possess the equipment, including specimens and control materials, and reference materials necessary in order to carry out their tasks as set out in Regulation (EU) 2017/746. As specimens, control materials and reference materials may be short-lived, the EU reference laboratories should have an acquisition plan in place to ensure their continuous availability. |
(5) |
In order to ensure compliance with the criterion regarding knowledge of international standards and best practices laid down in Article 100(4), point (c), of Regulation (EU) 2017/746, and given the variety and evolving nature of such international standards and best practices, the EU reference laboratories should identify which of those standards and practices apply to the activities within their scope of designation with a view to integrating them into their operating procedures. |
(6) |
In order to ensure that EU reference laboratories can assume legal responsibility as organisations for the tasks listed in Article 100(2) of Regulation (EU) 2017/746, they should be established as legal entities. In order to ensure continuity of operations, EU reference laboratories should be economically viable and have sources of funding. |
(7) |
As EU reference laboratories may receive a Union contribution in accordance with Article 100(6) of Regulation (EU) 2017/746, their administrative organisation should fulfil the conditions for recipients of Union funds laid down in Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (2). |
(8) |
In order to ensure compliance with the criterion regarding administrative organisation and structure laid down in Article 100(4), point (d), of Regulation (EU) 2017/746, the EU reference laboratories should have sufficient... |
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