Laboratories wishing to apply for designation as a reference laboratory of the European Union in the field of in vitro diagnostic medical devices must submit a request to the NAMMDR as a result of the call for applications officially launched by the Directorate-General for Health and Food Safety of the European Commission (DG SANTE), in line with Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices (IVDR).
In accordance with Article 100 paragraph (1) of Regulation (EU) 2017/746, applications can only be submitted by the member states of the European Union and Iceland, Norway, Liechtenstein, Turkey through their competent authorities, in Romania’s case, through the NAMMDR.
Laboratories intending to register for designation as an EU Reference Laboratory must strictly comply with several requirements and application deadlines.
Member States are required to submit registration applications for designation by 31 March 2023, 12:00 CET, through the competent authority of their Member State.
Extension of the deadline is not feasible and any application submitted after this deadline shall not be taken into consideration.
In order to meet this deadline, it is recommended that candidate laboratories submit their applications to their Member States by 12:00 CET on 5 January 2023.
The European Commission has published a guideline (Information pack) for candidate laboratories for designation as European Union reference laboratories, available for download:
The European Commission has dedicated a webpage to EU reference laboratories:
https://health.ec.europa.eu/vitro-diagnostics/eu-reference-laboratories_en
The tasks and criteria which must be fulfilled by reference laboratories of the European Union in the field of medical devices for in vitro diagnosis can be found in the 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 (https://eur-lex.europa.eu/legal-content/RO/TXT/PDF/?uri=CELEX:32022R0944&from=EN)
Information related to the fees which can be charged by reference laboratories of the European Union in the field of medical devices for in vitro diagnosis are mentioned in the Commission Implementing Regulation (EU) 2022/945 of 17 June 2022 laying down rules for the application of Regulation (EU) 2017/746 of the European Parliament and the Council.
This Regulation can be found here:
https://eur-lex.europa.eu/legal-content/RO/TXT/PDF/?uri=CELEX:32022R0945&from=EN
The European Commission will designate EU reference laboratories for a minimum period of 5 years with the possibility of extension, subject to continued compliance with the criteria.
The European Commission may, by means of an implementing act, suspend, withdraw or restrict the designation in case of noncompliance (see Article 100(9) of IVDR).
English shall be the working language for this designation process and the documentation submitted to the European Commission must be completed in English.
The interested persons are invited to contact the National Agency for Medicines and Medical Devices of Romania to obtain all the necessary information in order to register their candidacies at dgdm@anm.ro.