20.6.2022
EN
Official Journal of the European Union
L 164/9
(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