This implements the requirements of Art. 17 (3) and (5) of Regulation (EU) 2017/745 (“MDR”). The Implementing Regulation (available at: Implementing Regulation (EU) 2020/1207) comes into force on 09.09.2020. It will apply from 26.05.2021, i.e. from the date of application of the MDR.
Background
Single- use devices are those medical devices which are intended by the manufacturer to be used only on a single person for a single procedure. The permissibility of reprocessing such single-use devices within healthcare facilities is controversial in the EU. The question is also whether the single use is part of the manufacturer’s intended purpose and whether the reprocessing (in particular cleaning, disinfection, sterilization) and reuse is an off-label use that is generally not permitted for the user or operator of the medical device. In Germany, reprocessing is already regarded as permissible, not least for cost reasons.
The basic principles of reprocessing of single-use devices will in future be regulated in Art. 17 MDR. In order to be admissible at all, it must be permitted in the respective EU member state. If it is permitted, the reprocessor of the single-use device is generally considered the manufacturer within the meaning of the MDR (Art. 17 para. 2 MDR). The reprocessor must now meet all regulatory requirements of the MDR on his own responsibility. However, the requirements have been eased to allow the reprocessing of single-use devices in healthcare facilities (e.g. hospitals, doctors’ practices, nursing homes) if the products are also used there. This presupposes that the Member State concerned has decided that in this case not all manufacturer obligations are applicable (Art. 17 para. 3 MDR).
For Germany, it is planned to introduce new regulations in Sec. 8 para. 4 and 5 MPBetreibV-E (draft, available at: Draft of a regulation to adapt the medical device law to the regulation (EU) 2017/745 and the regulation (EU) 2017/746) explicitly and under simplified conditions. If the healthcare facilities use external reprocessors who return the reprocessed devices to the healthcare facility in their entirety after each reprocessing cycle, such service providers are also not required to comply with all manufacturer obligations, in deviation from Art. 17 para. 2 MDR.
Essential requirements for healthcare facilities and external reprocessors
If the reprocessing of single-use devices is permitted under these regulations, healthcare facilities or the external reprocessors commissioned by them must, among other things, ensure compliance with the Common Specifications (“CS”) pursuant to Art. 17 (3) and (5) MDR, which have now been adopted with the Implementing Regulation 2020/1207. For healthcare facilities, Sec. 8 para. 4 MPBetreibV-E (draft) shall refer to compliance with the CS, among other things. With the adherence to the CS the conformity with the requirements of the MDR, comparable to a harmonized standard, is presumed according to Art. 9 MDR. Nationally, the RKI-BfArM recommendation according to Sec. 8 Abs. 2 MPBetreibV should also be observed, which also leads to a legal presumption of proper reprocessing.
The CS according to Implementing Regulation (EU) 2020/1207 regulate the following requirements in particular:
- As part of the risk management, minimum requirements for staff, premises and equipment must be observed (Art. 4).
- Within the framework of the risk management, the health care institution must make a documented assessment of whether the single-use device is at all suitable for reprocessing (Art. 5)
- The reprocessing cycles and the maximum number of reprocessing cycles must be defined in advance (Art. 7 and 8).
- Technical documentation on reprocessing activities must be drawn up and kept for 10 years after the last reuse of a single-use product (Art. 9 MDR).
- The requirements for the procedures and steps of the respective reprocessing cycles, including labelling, must be observed in detail (Art. 10-20).
- Healthcare facilities must report all serious incidents involving reprocessed single-use devices (Art. 23).
- A specific traceability system must be established for reprocessed single-use devices (Art. 24).
- If the healthcare facility outsources the reprocessing of single-use devices to an external service provider, a written contract must be concluded, the minimum content of which is specified in Art. 3 para. 2.
Need for action
Operators of healthcare facilities that reprocess single-use devices for their own further use or have them reprocessed must implement the new requirements according to Art. 17 Para. 3 MDR in conjunction with the CS according to Implementing Regulation 2020/1207 as well as the new regulations in Sec. 8 MPBetreibV-E (draft) by 26.05.2021.
Companies and institutions that act as external reprocessors for healthcare facilities must implement the new requirements accordingly. Contracts between healthcare facilities and external reprocessors must be reviewed against the background of the CS that have now been defined and adapted to the minimum content specified in Art. 3 Para. 2 of the Implementing Regulation (EU) 2020/1207 by 26.05.2021.
Do you have questions about this news or do you want to discuss the news with the author? Please contact: Dr. Boris Handorn
