(Under forberedelse) Kommisjonens gjennomføringsforordning om fastsettelse av bestemmelser for anvendelse av europaparlaments- og rådsforordning (EU) 2017/745 med hensyn til felles spesifikasjoner for reprosessering av engangsutstyr
(In preparation) Commission Implementing Regulation laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards common specifications for the reprocessing of single-use medical devices
Høringsutkast til kommisjonsforordning publisert i Kommisjonens dokumentregister 18.3.2020
BAKGRUNN (fra kommisjonutkastet, engelsk utgave)
(1) Regulation (EU) 2017/745 allows reprocessing of single-use devices only where it is permitted by national law. As regards single-use devices that are reprocessed and used within a health institution, Regulation (EU) 2017/745 allows Member States not to apply all of the rules relating to manufacturers' obligations laid down in that Regulation. One of the conditions for such reprocessing is that it is performed in accordance with common specifications (‘CS’).
(2) To ensure the quality of the reprocessing activities, CS concerning risk management should include minimum requirements for staff, premises and equipment.
(3) Certain single-use devices are not suitable for reprocessing, for example, devices emitting radiation, devices used for administering cytostatic or radiopharmaceutical medicines, devices incorporating medicinal substances, devices for use in invasive procedures on the central nervous system, devices that pose a risk of transmission of spongiform encephalopathies, implantable devices, devices for which serious incidents have occurred after reprocessing and the cause of the incident is related to the reprocessing or it cannot be excluded that the cause of the incident is related to the reprocessing, devices with batteries which cannot be changed or present a risk of malfunctioning after reprocessing, devices with internal data storage which cannot be changed, devices with cutting or scraping blades, drills or components wearing off that are no longer suitable after the first use and cannot be changed or sharpened before the next medical procedure. CS concerning risk management should therefore include the analysis of the characteristics of single-use devices in terms of construction, material, properties and planned application, in order to assess the suitability of such single-use devices for reprocessing. It is therefore necessary to determine the characteristics of single-use devices to be taken into account within risk management procedures, so as to ensure the exclusion of those single-use devices that cannot safely be reprocessed due to their particular hazard potential or specific technical characteristics. Risk management should take into account the risks related to material composition, leachable material, microbiological contamination, prions and Transmissible spongiform encephalopathy agents, endotoxins, pyrogenic reactions, allergic reactions and toxic reactions, to assess whether single-use device is suitable for reprocessing. The technical specificities and geometrical properties of the products should also be taken into consideration when assessing suitability of single-use devices for reprocessing.
(4) To ensure the safety and performance of the reprocessed single-use device, CS concerning risk management should include the procedure by which the reprocessing process is established. In particular, the reprocessing process should be based on the characteristics of the single-use device and the results of a technical assessment. To ensure that the performance and safety of the reprocessed single-use device remains equivalent to the original device, it is necessary to determine a maximum number of reprocessing cycles which can be applied to the reprocessed single-use device.
(5) The general safety and performance requirements set out in Regulation (EU) 2017/745 apply to reprocessed single-use devices. Health institutions, together, when applicable, with the external reprocessors, are responsible for the safety and performance of the reprocessed device. The health institutions and external reprocessors should therefore have a quality management system ensuring that the relevant requirements are complied with. The quality management system should cover all parts and elements of the organisation regarding the reprocessing. In particular, the quality management system should show that the applicable processes for the reprocessing of single-use devices have been followed and that all conditions for a safe and effective reuse of the reprocessed device have been met. The quality management systems of a health institution and the external reprocessor acting on its behalf should be compatible, in order to ensure continuity of the reprocessing quality.
(6) In order to ensure the safety and performance of reprocessed single-use devices, each health institution using single-use devices reprocessed by the health institution itself or by an external reprocessor at the request of that health institution should have a system in place allowing them to collect information on serious incidents arising in connexion with such devices and should report serious incidents to the competent authority.
(7) The health institutions and the external reprocessors should have a system in place to ensure traceability of the reprocessed single-use device, notably as regards the reprocessing cycles conducted on a single-use device, the patients on which the reprocessed single-use device has been used and the final disposal of the reprocessed single-use device.
(8) The measures provided for in this Regulation are in accordance with the opinion of the Committee on Medical Devices
Helse- og omsorgsdepartementet