Commission Implementing Regulation (EU) 2020/1207

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THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC^note, and in particular Article 17(5) thereof,Whereas:

(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. 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, 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 characteristics and geometrical properties of the products should also be taken into consideration when assessing suitability of single-use devices for reprocessing. Based on these circumstances, examples of single-use devices that could be considered unsuitable for reprocessing include the following: 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 necessary for the use of the device and which cannot be changed or presents a risk of malfunctioning after reprocessing, 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.

(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 cycle is established. In particular, the reprocessing cycle 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 single-use device, it is necessary to determine a maximum number of reprocessing cycles which can be applied to the reprocessed single-use device while the performance and safety remain equivalent to the original 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 incidents arising in connection with such devices and should report serious incidents to the competent authority. The manufacturer and, when applicable, the external reprocessor should also be notified of serious incidents.

(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, and the final disposal of the reprocessed single-use device.

(8)The Medical Device Coordination Group has been consulted.

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

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Commission Implementing Regulation (EU) 2020/1207

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