Recitals 51 - 60 (MDR)


(51) Notified bodies' assessments of manufacturers' technical documentation, in particular documentation on clinical evaluation, should be critically evaluated by the authority responsible for notified bodies. That evaluation should be part of the risk-based approach to the oversight and monitoring activities of notified bodies and should be based on sampling of the relevant documentation.


(52) The position of notified bodies vis-à-vis manufacturers should be strengthened, including with regard to their right and duty to carry out unannounced on-site audits and to conduct physical or laboratory tests on devices to ensure continuous compliance by manufacturers after receipt of the original certification.


(53) To increase transparency with regard to the oversight of notified bodies by national authorities, the authorities responsible for notified bodies should publish information on the national measures governing the assessment, designation and monitoring of notified bodies. In accordance with good administrative practice, this information should be kept up to date by those authorities in particular to reflect relevant, significant or substantive changes to the procedures in question.


(54) The Member State in which a notified body is established should be responsible for enforcing the requirements of this Regulation with regard to that notified body.


(55) 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.


(56) For class III implantable devices and class IIb active devices intended to administer and/or remove a medicinal product, notified bodies should, except in certain cases, be obliged to request expert panels to scrutinise their clinical evaluation assessment report. Competent authorities should be informed about devices that have been granted a certificate following a conformity assessment procedure involving an expert panel. The consultation of expert panels in relation to the clinical evaluation should lead to a harmonised evaluation of high-risk medical devices by sharing expertise on clinical aspects and developing CS on categories of devices that have undergone that consultation process.


(57) For class III devices and for certain class IIb devices, a manufacturer should be able to consult voluntarily an expert panel, prior to that manufacturer's clinical evaluation and/or investigation, on its clinical development strategy and on proposals for clinical investigations.


(58) It is necessary, in particular for the purpose of the conformity assessment procedures, to maintain the division of devices into four product classes in line with international practice. The classification rules, which are based on the vulnerability of the human body, should take into account the potential risks associated with the technical design and manufacture of the devices. To maintain the same level of safety as provided by Directive 90/385/EEC, active implantable devices should be in the highest risk class.


(59) Rules under the old regime applied to invasive devices do not sufficiently take account of the level of invasiveness and potential toxicity of certain devices which are introduced into the human body. In order to obtain a suitable risk-based classification of devices that are composed of substances or of combinations of substances that are absorbed by or locally dispersed in the human body, it is necessary to introduce specific classification rules for such devices. The classification rules should take into account the place where the device performs its action in or on the human body, where it is introduced or applied, and whether a systemic absorption of the substances of which the device is composed, or of the products of metabolism in the human body of those substances occurs.


(60) The conformity assessment procedure for class I devices should be carried out, as a general rule, under the sole responsibility of manufacturers in view of the low level of vulnerability associated with such devices. For class IIa, class IIb and class III devices, an appropriate level of involvement of a notified body should be compulsory.

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