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)
Commission Implementing Regulation (EU) 2022/944of 17 June 2022laying 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/EUOJ L 117, 5.5.2017, p. 176., 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 CouncilRegulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1)..(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 administrative staff and keep documentation demonstrating their structure and organisational procedures, as well as records of costs and fees levied and a yearly overview of the tasks performed.(9)In order to ensure compliance with the criterion regarding confidentiality laid down in Article 100(4), point (e), of Regulation (EU) 2017/746, EU reference laboratories should ensure that their staff handles, stores and processes confidential information and data in an appropriate manner and should take measures to prevent undue disclosure of such information, in accordance with Directive (EU) 2016/943 of the European Parliament and of the CouncilDirective (EU) 2016/943 of the European Parliament and of the Council of 8 June 2016 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure (OJ L 157, 15.6.2016, p. 1)..(10)In order to ensure compliance with the criterion regarding public interest and independence laid down in Article 100(4), point (f), of Regulation (EU) 2017/746, a competent authority should confirm that a laboratory for which a Member State or the Commission’s Joint Research Centre submitted an application for designation as EU reference laboratory performs tasks of public interest in the proposed scope of designation.(11)In order to ensure compliance with the criterion laid down in Article 100(4), point (g), of Regulation (EU) 2017/746 regarding the impartiality of staff, the EU reference laboratories should be required to put in place a policy to identify and prevent, on a continuous basis, any conflict of interest of their staff in relation to the fulfilment of the tasks of the EU reference laboratories.(12)Considering the volume, specific nature and potential novelty of the laboratory testing that may be required from the EU reference laboratories within their scope of designation, those laboratories should be entitled to request support for laboratory testing activities from national reference laboratories and other laboratories established in a Member State (collectively referred to as "external laboratories") or from other EU reference laboratories in terms of equipment and staff. This Regulation should establish the rules for the provision of such outsourcing that are necessary to ensure compliance with the criteria laid down in Article 100(4) of Regulation (EU) 2017/746. Regardless of the support received from any other laboratory, the EU reference laboratory requested to perform the task should bear the responsibility for the final opinions, findings or recommendations.(13)The requirements laid down in the harmonised standard EN ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories) are appropriate for EU reference laboratories. Therefore accreditation in accordance with that standard, the reference of which has been published in the Official Journal of the European Union, by a national accreditation body, operating in accordance with Regulation (EC) No 765/2008 of the European Parliament and of the CouncilRegulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30)., should be a means for laboratories to demonstrate conformity with the relevant requirements of this Regulation.(14)Considering that the Commission may only designate, as EU reference laboratories, laboratories for which a Member State or the Commission’s Joint Research Centre have submitted an application for designation, Member States should be required to verify the compliance of the laboratories for which they intend to submit an application with the criteria laid down in Article 100(4) of Regulation (EU) 2017/746, as further specified in this Regulation, prior to submitting the application. The Commission’s Joint Research Centre should verify that it complies with the criteria if it intends to submit an application for its designation as an EU reference laboratory.(15)The tasks that the EU reference laboratories are to carry out within their scope of designation are set out in Article 100(2) of Regulation (EU) 2017/746. The Commission is to lay down detailed rules to facilitate the application of that provision.(16)In order to ensure clarity, certainty and transparency, tasks requested of EU reference laboratories by notified bodies and Member States should be performed in accordance with predetermined terms and conditions. Therefore, such activities should be covered by a contract between the requesting parties and the EU reference laboratories. With regard to the verification of performance, the verification of compliance with common specifications or with other solutions chosen by the manufacturer and the sample or batch testing referred to in Article 100(2), points (a) and (b), of Regulation (EU) 2017/746, the notified body should lodge a request with only one EU reference laboratory for a given task and device in order to prevent parallel assessments of the same device by several EU reference laboratories.(17)In order to carry out the verification of performance, the verification of compliance with common specifications or with other solutions chosen by the manufacturer and the sample or batch testing referred to in Article 100(2), points (a) and (b), of Regulation (EU) 2017/746, the EU reference laboratories need information specific to the device to be tested. The notified body, as the requestor of the task, should be required to provide that information. In case the EU reference laboratory needs to clarify that information, any communication between the EU reference laboratory and the notified body should be documented in order to ensure independence of the EU reference laboratory and traceability.(18)In order to enable testing of devices for which the manufacturer has specifically developed or prescribed equipment or reference materials, the notified bodies should ensure that the EU reference laboratories have access to such equipment and materials free of charge. To ensure correct use of the equipment and materials, the EU reference laboratory staff should have access to training in that regard.(19)To ensure access to the market for safe and performing devices, the EU reference laboratories should not refuse requests from notified bodies for a contract to perform the tasks referred to in Article 100(2), points (a) and (b), of Regulation (EU) 2017/746 that are in their scope of designation.(20)To ensure independence when carrying out the verification of performance, the verification of compliance with common specifications or with other solutions chosen by the manufacturer referred to in Article 100(2), point (a), of Regulation (EU) 2017/746, the EU reference laboratories should decide which tests are necessary taking into account the performance claimed and duly substantiated by the manufacturer.(21)In order to ensure legal certainty, it is necessary to clarify the starting point for the period of 60 days which the EU reference laboratories have at their disposal for providing the opinion referred to in Section 4.9 of Annex IX to Regulation (EU) 2017/746 and Section 3, point (j), and Section 5.4 of Annex X to that Regulation.(22)In order to operate in a transparent manner, the EU reference laboratories should provide sufficient reasons for their conclusions regarding the verification of performance, the verification of compliance with common specifications or with other solutions chosen by the manufacturer and the sample or batch testing referred to in Article 100(2), points (a) and (b) of Regulation (EU) 2017/746. Those reasons should be included in the opinions or findings provided by the EU reference laboratories.(23)In order to ensure consistent assessments of devices and facilitate subsequent sample or batch testing by EU reference laboratories, the opinion referred to in Section 4.9 of Annex IX to Regulation (EU) 2017/746 and Section 3, point (j), and Section 5.4 of Annex X to that Regulation should contain recommendations on subsequent sample or batch testing to be carried out by the same EU reference laboratory or by other EU reference laboratories.(24)Notified bodies should establish a plan for sample or batch testing in order to ensure appropriate product verification. In order to allow the notified bodies to benefit from the expertise of the EU reference laboratories in the context of the sample or batch testing referred to in Article 100(2), point (b), of Regulation (EU) 2017/746, the EU reference laboratory should be given the opportunity to propose changes to the notified body’s plan for sample or batch testing, including the reasons for such changes. To ensure coherence in the assessment of the device, the final plan established by the notified body should take into account all relevant information, including the recommendations on sample or batch testing set out in the EU reference laboratory opinion referred to in Section 4.9 of Annex IX to Regulation (EU) 2017/746 and Section 3, point (j), and Section 5.4 of Annex X to that Regulation and the results of any previous sample or batch tests performed on the device.(25)Having regard to Section 4.13 of Annex IX to Regulation (EU) 2017/746 and Section 5.2 of Annex XI to that Regulation (EU) 2017/746, logistic arrangements should be made to ensure sufficient time for the EU reference laboratory to perform the testing and provide its findings to the notified body, taking into account the need for the notified body to communicate a possible decision to the manufacturer within the timeframe agreed with the manufacturer, but not later than 30 days after reception of the samples.(26)The tasks referred to in Article 100(2), points (c), (d), (f), (g), (h) and (i), of Regulation (EU) 2017/746 may concern horizontal matters which should be treated in a harmonised manner. Therefore, where a task falls within the scope of designation of more than one EU reference laboratory, all of those EU reference laboratories should be involved in fulfilling that task.(27)Where requests from notified bodies for tasks referred to in Article 100(2), points (c), (d) and (g), of Regulation (EU) 2017/746, concern more than one notified body, they should coordinate with each other to ensure consistent conformity assessments of devices across the Union.(28)In order to enable the EU reference laboratories to set up and manage a network of national reference laboratories as referred to in Article 100(2), point (e), of Regulation (EU) 2017/746, it should be specified how such national reference laboratories are to be identified and how the networks are to be established and managed.(29)For the purposes of the task referred to in Article 100(2), point (h), of Regulation (EU) 2017/746, namely to provide recommendations on suitable reference materials and reference measurement procedures of higher metrological order, the EU reference laboratories should maintain a public list of such materials and procedures within their scope of designation, as such information is of general interest to the relevant actors across the Union.(30)The assistance, advice, contributions and recommendations provided by EU reference laboratories should follow relevant standards. Should this not be the case, for example as a result of limited availability of materials that comply with relevant standards, EU reference laboratories should, in order to ensure transparency, provide an appropriate justification for the use of methods, practices and materials that diverge from those standards.(31)To perform their tasks in a harmonised manner, it is essential that the EU reference laboratories exchange experience on specialised topics. To that end, the EU reference laboratories should, within the network of EU reference laboratories referred to in Article 100(5) of Regulation (EU) 2017/746 (the "EU reference laboratories’ network"), form sub-networks corresponding to a specific device, category or group of devices or a specific hazard related to a category or group of devices, or covering other specific topics. The sub-networks should regularly compare test results to ensure the consistency of those results across EU reference laboratories.(32)In order to ensure that the EU reference laboratories carry out their tasks in a harmonised manner, common rules of procedure for all EU reference laboratories should be established in agreement with the Commission. Those common rules of procedure should be publicly available, for reasons of transparency, and reviewed regularly to ensure that they are efficient and up-to-date with the state of the art.(33)The measures provided for in this Regulation are in accordance with the opinion of the Committee on Medical Devices,HAS ADOPTED THIS REGULATION: