Recitals 51 - 60 (IVDR)


(51) In view, in particular, of the responsibility of Member States for the organisation and delivery of health services and medical care, they should be allowed to lay down additional requirements on notified bodies designated for the conformity assessment of devices and established on their territory as far as issues that are not regulated in this Regulation are concerned. Any such additional requirements laid down should not affect more specific horizontal Union legislation on notified bodies and equal treatment of notified bodies.


(52) For class D devices, competent authorities should be informed about certificates granted by notified bodies and be given the right to scrutinise the assessment conducted by notified bodies.


(53) For class D devices for which no CS exist it is appropriate to provide that where it is the first certification for that specific type of device and there is no similar device on the market having the same intended purpose and based on similar technology, notified bodies should, in addition to the laboratory testing of the performance claimed by the manufacturer and the compliance of the device by the EU reference laboratories, be obliged to request expert panels to scrutinise their performance evaluation assessment reports. The consultation of expert panels in relation to the performance evaluation should lead to a harmonised evaluation of high-risk in vitro diagnostic medical devices by sharing expertise on performance aspects and developing CS on categories of devices that have undergone that consultation process.


(54) To enhance patient safety and to take due account of technological progress, the current classification system for devices set out in Directive 98/79/EC should be fundamentally changed, in line with international practice, and the corresponding conformity assessment procedures should be accordingly adapted.


(55) It is necessary, in particular for the purpose of the conformity assessment procedures, to classify devices in four risk classes and to establish a set of robust risk-based classification rules, in line with international practice.


(56) The conformity assessment procedure for class A devices should be carried out, as a general rule, under the sole responsibility of manufacturers, since such devices pose a low risk to patients. For class B, class C and class D devices, an appropriate level of involvement of a notified body should be compulsory.


(57) The conformity assessment procedures for devices should be further strengthened and streamlined whilst the requirements for notified bodies as regards the performance of their assessments should be clearly specified to ensure a level playing field.


(58) It is appropriate that certificates of free sale contain information that makes it possible to use Eudamed in order to obtain information on the device, in particular with regard to whether it is on the market, withdrawn from the market or recalled, and on any certificate on its conformity.


(59) It is necessary to clarify the requirements regarding batch release verification for the highest risk devices.


(60) EU reference laboratories should be enabled to verify by laboratory testing the performance claimed by the manufacturer and the compliance of devices presenting the highest risk with the applicable CS, when such CS are available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent.

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