by Giuliana Miglierini
Reprocessing and reusing are one of the key actions central to many new EU policies targeting the Green transition. To this instance, the European Commission published on 10 April 2024 the final report of the “Study on the implementation of Article 17 of Regulation (EU) 2017/745 on medical devices on the EU market”, focusing on how the provisions of Art. 17 have been implemented by the 27 EU Member States (+Iceland, Liechtenstein and Norway). The study was com-missioned in December 2022 to the Austrian National Public Health Institute (Gesundheit Österreich GmbH), which conducted it in collaboration with S&P Global, Areté and Civic Consulting.
Based on the results of the study, which included a survey among four different stakeholder groups (competent authorities, notified bodies designed under the MDR, reprocessors regarded as manufacturers of the reprocessed single-use devices, and health institutions reprocessing single-use devices), an online dashboard has been also developed to navigate the main outcomes.
Reprocessing and reusing
According to Article 17 of Regulation (EU) 2017/745 on medical devices (MDR), single-use devices (SUDs; Art. 2(8) MDR) and their reprocessing fall under the topics that member states can regulate by national law. This implies that SUDs reprocessing may be allowed in certain EU countries and not in others.
Common Specifications (CS) for the reprocessing of single-use devices have been detailed by the Commission in the Implementing Regulation (EU) 2020/1207 of 19 August 2020, in order to support a more harmonised approach across different countries.
According to the study, the term “reprocessing” (Art. 2(39) MDR) refers to a process carried out on a used device in order to allow its safe reuse. It includes its cleaning, disinfection, sterilisation and related procedures, as well as testing and restoring the technical and functional safety of the used device. A reprocessing cycle includes all steps needed to ensure that the safety and performance of the reprocessed device is equivalent to that of the original product. Reprocessors are identified with health institutions or external entities reprocessing single-use devices.
Medical devices can be single-use or reusable. The first category includes devices intended to be used just on one individual during a single procedure. On the other hand, reusable medical de-vices support repeated or multiple uses, provided they are reprocessed according to the specific instructions for decontamination, cleaning, disinfection or sterilisation between uses. Limits for reprocessing and reuse are also provided by the MDR.
The study’s Glossary specifies that the term “reuse” refers to the repeated use or multiple use of any medical device, including devices intended for reuse or single use, with reprocessing bet-ween uses.
There is a slight nuance in the MDR with respect to the reprocessing of single-use or reusable medical devices. The regulation specifically mentions reprocessing with reference to the reuse of single-use devices. This is not the case for reusable ones, for which reference is made to ‘the appropriate processes for allowing reuse, […] appropriate to the Member State or Member States in which the device has been placed on the market’. This difference eventually impacts requirements and responsibilities for reprocessing, as single-use devices can be re-processed only if allowed by national laws.
In the case reprocessing is allowed, according to Art. 17(3) MDR the reprocessor will assume the obligations laid down in MDR that are required of manufacturers. In such an instance, the original manufacturer will continue to appear on the Instructions for Use but will not be mentioned on the label.
EU countries can derogate to these provisions, limiting the application of the rules relating to manufacturers obligations in the case of SUDs reprocessed and used within a health institution. All national laws on reprocessing of single-use devices introduced by Article 17(3) MDR have to be notified to the EU Commission. In case reprocessing is allowed, national rules may even be stricter than the ones included in the MDR (Art. 17(9)).
The main outcomes of the study
The study used a mixed-methods approach, and a survey run among the four different categories of stakeholders to analyse the current market situation for the reprocessing and reuse of single-use devices in Europe.
Surveys among competent authorities on medical devices, notified bodies and manufacturers were run twice (in spring-summer and in November December 2023), in order to capture the situation up to the end of 2023. All competent authorities (30) and notified bodies (38) responded to the first survey, and almost all to the second one (27/30 and 35/42, respectively). Two manufacturers were contacted and responded in the second phase. In the case of health authorities, more than half (27/46, 59%) of the received responses were excluded from the analysis, and no survey was conducted. Some targeted interviews with stakeholders were also run.
Data from competent authorities indicate that reprocessing of single-use devices is allowed in 10 European countries (33,33%): Belgium, Croatia, Denmark, Germany, Ireland, Island, Nether-lands, Poland, Spain, and Sweden. The dashboard also offers details of the relevant national rules.
Only a small portion (6; 15,79%) of notified bodies (NBs) are certifying reprocessed single-use devices. NBs received only 2 requests for conformity assessment (CE mark) and one for compliance with Common Specifications, and no certificate for reprocessed SUDs has been issued so far. Single-use devices to be certified fall mainly in class IIa, IIb and III devices, including for example cardiovascular, arthroscopic/orthopedic or laparoscopic devices.
Many notified bodies (11) have not been designated to certify reprocessed SUDs or compliance to CS. In other cases, they indicated a lack of resources (11) or an unclear liability (5). According to notified bodies (as well as to other stakeholders), optimisation of reprocessing should require among others better identification of suitable products, regulatory requirements and a clear tracking system.
As for manufacturers, the only two respondents are both SMEs; they are either specialised in reprocessing of SUDs (50%) or also of multiple use devices (50%). Reprocessed single-use devices are made available mainly in Germany, Belgium, Ireland, Netherlands and other non-EU countries. The main challenge identified by manufacturers is the lack of notified bodies for certification of the reprocessed devices.
More than half of the considered health institutions (10; 52,63%) are not reprocessing SUDs. The survey also shows respondents (9) have not a certificate or written agreement in place with a notified body for certification of compliance to Common Specifications.Traceability of reprocessed devices, product release and performance testing, risk management system, validation of the entire process procedures are among the main challenges identified by health authorities with regard to the implementation of CS or national provisions.