The Draft is to implement the requirements of Article 17(3) of the Medical Devices Regulation 2017/943 (hereafter “MDR”). Article 17 MDR provides that under certain conditions, health institutions can reprocess single-use medical devices.
One of the requirements is that the European Commission adopts “Common Specifications” (hereafter “CS”). The Draft provides for the CS.
The European Commission has published the Draft and intends to collect input from stakeholders as part of a public consultation running until 20 August 2019.
Article 2 (39) MDR provides that ‘health institution’ is to be understood as an organisation with the care or treatment of patients or the promotion of public health as its primary purpose . This notion does not cover organisations promoting health interest or healthy lifestyles, such as gyms or wellness and fitness centres. Article 17 (1) MDR provides that entities can only reprocess single-use medical devices if permitted by national EU Member State law.
Article 17 (2) MDR provides that the natural or legal person who reprocesses a single use medical device is considered to be the legal manufacturer of the reprocessed medical devices. The reprocessor of the single use medical device has to assume the responsibility and obligations of a legal manufacturer of the medical device.
Article 17 (3) MDR provides for an exemption to the abovementioned rule. EU Member States can exempt reprocessors of single-use medical devices that are reprocessed within a health institution, from some of the obligations of a legal manufacturer of a medical device. It is up to the EU Member State to adopt rules concerning the exemptions to the obligations of a legal manufacturer.
Article 17 (3) provides that EU Member States can provide for the exemption if the EU Member States ensure:
- that there is an equivalence of safety and performance between the original and the reprocessed device; and
- that the reprocessing is performed in accordance with CS.“A set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system.”The Draft will provide for the CS that must be complied with by Member States when they choose to apply article 17(3) MDR.
Article 2 (71) MDR provides that common specifications (CS) are:
“A set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system.”
These CS include requirements concerning risk management, validation of procedures for the entire (re)process, a quality management system, reporting of incidents and traceability.
The Draft will provide for the CS that must be complied with by Member States when they choose to apply article 17(3) MDR.
The draft commission implementing Regulation
The Draft provides CS for the reprocessing within a health institution. The Draft distinguishes between two types of reprocessors of single-use medical devices within a health institution:
- health institutions reprocessing a single-use medical device themselves; and
- external entities reprocessing the single-use medical device at the request of the health institution.
This difference made by the Regulation is then structured around four main requirements of the CS: (1) risk management, (2) reprocessing procedures, (3) quality management system and (4) traceability.
In order to ensure the quality of the reprocessing activities, the draft regulation proposes minimum requirements for staff, premises and equipment. Characteristics of single-use devices can be taken into account to determine the minimum requirements.
Article 3 of the Draft provides that the health institution and the external reprocessor have to conclude a written agreement. Article 4 of the Draft lays down minimum requirements regarding the personnel involved in the reprocessing of the single-use medical device, the premises where the reprocessing takes place and the equipment used in the process. Article 5 of the Draft provides for a preliminary assessment of the suitability and article 6 of the Draft for necessity to keep the original intended purpose of the single-use device.
Regarding the reprocessing process itself, article 7 of the Draft provides that health institutions shall determine this process using information and documentation gathered in accordance with Article 5. Article 8 provides for a limitation of the maximum number of reprocessing cycles. Finally, article 9 lists the technical documentation required regarding the reprocessing activities.
Articles 10 to 20 of the Draft focus on reprocessing procedures as they are at the heart of the reprocessing of single-use devices. These articles cover the entire process of the procedures from the validation of the procedures to the supply of single-use medical devices. Visual, physical and hygienic checks of single-use devices are envisaged in the prior phase of validation of procedures. Steps of the process include inter alia the treatment at the point of use prior to reprocessing, cleaning, disinfection, packaging and labelling.
Quality management system
The health institutions and external reprocessors are responsible for the general safety and performance requirements set out in the MDR. To comply with the General Safety and Performance Requirements of the MDR, articles 21 to 23 of the Draft provide that the health institutions and external reprocessors need to have a quality management system (QMS) including procedures on the reporting of adverse events.
Single-use medical devices may be reprocessed several times. The draft Regulation provides that health institutions and external reprocessors must operate a traceability system to keep track of reprocessing cycles of the single-use devices.
Importantly, reprocessors shall store all records regarding all steps of the reprocessing process, for a period of at least five years after the last reprocessing of a single-use device.
The public consultation
The draft implementing Regulation on reprocessing of single-use medical devices is open for feedback until the 20 August 2019 (midnight Brussels time).
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Authored by Fabien Roy, Alexander Wenzel and Gregoire Paquet