Single use medical device reprocessing has always been a challenge for many health institutions. The new medical device regulation (MDR) EU 2017/745 defines requirements for “single-use devices and their reprocessing” in Article 17. On 19th of August 2020, EU commission issued the implementing regulation 2020/1207 as regards common specifications (CS) for the reprocessing of single-use devices. Although the issue of this implementing regulation made an impression like the commission allows reprocessing of single use medical devices, the process has strict prerequisites. Let’s have a detailed look….
A single use medical device means a device that is intended by its legal manufacturer to be used on one individual during a single procedure. Article 17 of MDR allows the reprocessing of a single use device by a health institution or by its external reprocessor under certain circumstances.
Firstly, reprocessing, and further use of single-use devices may only take place where permitted by national law of a member state. Secondly the member state may decide not to apply all of the rules relating to manufacturers’ obligations laid down in MDR EU 2017/745 for the reprocessor (which is considered as the manufacturer) provided that they ensure;
- Safety and performance of the reprocessed device is equal to the original device,
- The health institution performing the reprocessing complies with the applicable requirements of Article 5(5) of MDR,
- The reprocessing is performed in accordance with the common specification EU 2020/1207,
According to Article 17 of MDR, the reprocessing of a single-use device is only allowed, when it is considered safe according to the latest scientific evidence. On the other hand, the member state which permits single use medical device reprocessing may maintain or introduce national provisions that are stricter than those laid down in MDR EU 2017/745.
The Common Specification EU 2020/1207 gives a long list of single-use medical devices that are considered unsuitable for reprocessing. The key point is an intensive risk assessment including the analysis of the characteristics of single-use medical devices in terms of construction, material, properties and planned application. This shall be performed and documented before giving the reprocessing decision.
According to the requirements listed in EU 2020/1207, the reprocessor has similar obligations with the legal manufacturer. The heath institution or its external reprocesses shall implement a quality management system as required in Chapter IV of the CS to ensure the safety and performance of the medical device without changing the original intended use and prepare the technical documentation. The system shall ensure that all applicable requirements (procedures and reprocessing steps) listed in Chapter III are fulfilled. In addition to this, the quality management system shall be audited at least annually by an independent external body and the report shall be made available to the notified body competent for the certification of the reprocessor.
Another important point is the definition of the maximum number of reprocessing cycles. As defined on Article 8 (1) of EU 2020/1207 each reprocessing cycle shall be counted to determine the maximum number of reprocessing cycles even if the single-use device was not reused on a patient. The heath institution or its external reprocesses shall implement the validation requirements as defined on Article 7 of the CS.