(fra kommisjonsforordningen)

(1) Regulations (EU) 2017/745 and (EU) 2017/746 establish a regulatory framework to ensure the smooth functioning of the internal market as regards medical devices and in vitro diagnostic medical devices, taking as a base a high level of protection of health for patients and users. At the same time, those Regulations set high standards of quality and safety for medical devices and in vitro diagnostic medical devices in order to meet common safety concerns as regards such devices.

(2) Under Regulations (EU) 2017/745 and (EU) 2017/746, notified bodies are designated to perform conformity assessments activities for the certification of, respectively, medical devices and of in vitro diagnostic medical devices. For this purpose, notified bodies should comply with certain requirements that are necessary to fulfil their tasks, namely with the requirements laid down in Annex VII to Regulation (EU) 2017/745, as regards medical devices, and in Annex VII to Regulation (EU) 2017/746 as regards in vitro medical devices.

(3) The application of Regulations (EU) 2017/745 and (EU) 2017/746 has shown inconsistent and divergent interpretations of certain requirements set out in Annex VII to Regulation (EU) 2017/745 and in Annex VII to Regulation (EU) 2017/746 as regards quotations provided by notified bodies to manufacturers, the timelines for completing conformity assessment activities and re-certification. Quality management and procedural requirements should be further detailed and clarified to ensure that they are implemented in a uniform manner.

(4) The individual practices that notified bodies apply as regards quality management and procedural requirements diverge significantly, thus putting manufacturers in unequal positions across the internal market. This is particularly relevant in case of manufacturers that are small and medium-sized enterprises. Such practices have an impact on the predictability and on the timely completion of conformity assessment activities, with significant repercussions and delays for innovation and the health of patients.

(5) Notified bodies showed significantly differing practices when issuing quotations to manufacturers for specific conformity assessment activities. As a result, manufacturers are not provided with a reliable estimation of the overall requested services and costs. To harmonise notified bodies’ practices, this Regulation should specify the minimum information notified bodies should request to issue a quotation, to ensure that the related following applications for conformity assessment activities are not rejected because they are incomplete or because the device is outside the scope of the notified body’s designation. Notifies bodies should ask information on the device(s), their intended purpose, any specific characteristics or specific technologies or processes used, to allow them to verify they are designated for the corresponding codes, provided for in Commission Implementing Regulation (EU) 2017/2185 (3).

(6) For the purpose of obtaining quotations, manufacturers should provide information to notified bodies which allows them to conclude whether a manufacturer is to be considered as a micro, small and medium-sized enterprise taking into consideration in Commission Recommendation 2003/361/ΕC concerning the definition of micro, small and medium-sized enterprises (4).

(7) Based on complete information on the scope of the conformity assessment, notified bodies should issue quotations that include a clear estimation of the costs the manufacturer should expect. Such costs should be presented to the manufacturer according to a clearly presented breakdown and, possibly, include costs for the surveillance activities when such activities are required during the certification cycle.

(8) In order to provide quotations in accordance with this Regulation based on sufficiently detailed information, notified bodies should make use of available opportunities to enhance the efficiency and predictability of their conformity assessment activities, such as through structured dialogues with manufacturers especially in the pre-application phase.

(9) Notified bodies have developed varying practices for interacting with manufacturers, leading to different procedures for setting timelines for the conformity assessment activities. This results in conformity assessment activities being completed across a wide range of timelines, often lacking a clear rationale for how these timelines are determined.

(10) In the interest of promoting the safe and continuous supply of the public, notified bodies should complete the conformity assessment activities for a medical device or for an in vitro diagnostic medical device in the shortest feasible timeline needed for the required assessment or, at the latest, within a maximum timeline.

(11) Based on the individual conformity assessment activities required for device certification, notified bodies and manufacturers should agree on timelines for completing these activities, ensuring they do not exceed maximum limits.

(12) Maximum timelines should be set taking into consideration the variety of devices and specificities of the conformity assessment activities that notified bodies have to carry out. A maximum timeline should be set for the assessment of the application for a conformity assessment procedure and the signature of the contract between the notified body and the manufacturer. Where a framework agreement exists between the notified body and the manufacturer, the signature of the contract should be understood as the signature of the contract for the specific conformity assessment activity.

(13) Due to the need to carry out activities at the manufacturer’s premises or, where relevant, at the premises of certain suppliers or sub-contractors of the manufacturer, timelines for quality management system auditing should be differentiated from those for the product verification. Such differentiation should not prevent that conformity assessment activities for product verification and for quality management system are conducted in parallel when carried out in accordance with Annex IX to Regulation (EU) 2017/745 and Annex IX to Regulation (EU) 2017/746, provided that the required input from the assessment of the technical documentation is taken into account when developing the audit programme.

(14) Timelines for product verification should be specific to class III or class IIb implantable devices and to class D in vitro diagnostic medical devices. Timelines should also apply in case of assessment of the technical documentation for a representative device on a sampling basis for other class IIb or IIa devices, as well as for class B and class C devices and for specific in vitro diagnostic medical devices, such as companion diagnostics, near-patient testing and self-testing devices.

(15) Maximum timelines for quality management system auditing and product verification, including product review, should also take into account the need to properly follow up on potential non-compliances raised during the assessment.

(16) Timelines should be set for the conformity assessment of planned substantial changes to the quality management system or the range and type of the devices and to the changes to the approved device. A maximum timeline should be set for the notified body’s assessment of the notification to decide if additional conformity assessment activities are to be carried out. A maximum timeline should be set also for those eventual additional conformity assessment activities to be performed.

(17) A maximum timeline should be set also for the decision and for the issuance of the certificate(s) or the supplement(s) to already issued certificate(s) for which the manufacturer informed notified bodies of a planned change. This timeline should allow notified bodies to issue their decision based on the assessment performed.

(18) Notified bodies should interrupt the timeline of a conformity assessment activity where the completion of such an activity depends upon further information to be provided by the manufacturer. The timeline should also be interrupted where the completion of the activity depends on the contribution of the European Medicinal Agency (EMA), a regulatory authority, an expert panel or of an EU reference laboratory, as long as the notified bodies’ activities depend exclusively on those contributions.

(19) Notified bodies should have appropriate arrangements, within their quality management systems, to monitor their performances on timelines and on how predicted costs in quotations correspond to actual costs charged for conformity assessment activities. To ensure that such information of public interest is available and presented in a clear and harmonised manner, notified bodies should prepare reports that provide data on the monitoring of timelines and costs. Notified bodies should publish the reports on their websites, to ensure transparency on their performances and to allow manufacturers to compare information between notified bodies, and inform the authority responsible for the notified body and the Commission.

(20) Notified bodies perform the re-certification of medical devices and of in vitro medical devices in a divergent manner. The practical application of requirements related to the relevant manufacturer documentation and to the extent of the related review results in a wide range of practices from targeted assessment of limited documentation to more comprehensive assessments that have comparable extent of those for the initial product verification. This results in huge differences in re-certification processes and relevant timelines and costs thereof.

(21) Notified bodies should perform re-certification according to predictable timelines and without repeating the assessment performed during the initial certification. Information and extracts of the technical documentation that should be subject to assessment should be clearly identified both for the renewal of quality management system and product certificates.

(22) Notified bodies should focus the assessment of the quality management system subject to re-certification in particular on information related to surveillance activities, compliance with applicable sampling plans, non-compliances and corrective or preventive actions and eventual conditions to the certificate. The assessment should take into consideration also the state of the art.

(23) Notified bodies should focus the assessment of information related to the device subject to re-certification in particular on information provided by the manufacturer on post market surveillance, changes to the device, also related to the evolution of the state of the art, and updates to the risk analysis.

(24) The measures provided for in this Regulation are in accordance with the opinion of the Committee on Medical Devices,