Remanufacturing / reprocessing
What is it?
Remanufacturing (also known is reprocessing), is a process carried out on a medical device in order to allow its safe reuse, including cleaning, disinfection, sterilisation and related procedures, as well as testing and restoring the technical and functional safety of the medical device, according to EU MDR 2017/745/EU.
EU MDR 2017/745 EU in English:
EU MDR 2017/745 EU in various languages:
Read the article single-use devices and their reprocessing (Article 17 of the regulation EU MDR 2017/45)
1.Reprocessing and further use of single-use devices may only take place where permitted by national law and only in accordance with this Article.
2.Any natural or legal person who reprocesses a single-use device to make it suitable for further use within the Union shall be considered to be the manufacturer of the reprocessed device and shall assume the obligations incumbent on manufacturers laid down in this Regulation, which include obligations relating to the traceability of the reprocessed device in accordance with Chapter III of this Regulation. The reprocessor of the device shall be considered to be a producer for the purpose of Article 3(1) of Directive 85/374/EEC.
3.By way of derogation from paragraph 2, as regards single-use devices that are reprocessed and used within a health institution, Member States may decide not to apply all of the rules relating to manufacturers’ obligations laid down in this Regulation provided that they ensure that:
(a) the safety and performance of the reprocessed device is equivalent to that of the original device and the requirements in points (a), (b), (d), (e), (f), (g) and (h) of Article 5(5) are complied with;
(b) the reprocessing is performed in accordance with CS detailing the requirements concerning:
— risk management, including the analysis of the construction and material, related properties of the device (reverse engineering) and procedures to detect changes in the design of the original device as well as of its planned application after reprocessing,
— the validation of procedures for the entire process, including cleaning steps,
— the product release and performance testing,
— the quality management system,
— the reporting of incidents involving devices that have been reprocessed, and
— the traceability of reprocessed devices.
Member States shall encourage, and may require, health institutions to provide information to patients on the use of reprocessed devices within the health institution and, where appropriate, any other relevant information on the reprocessed devices that patients are treated with. 5.5.2017 L 117/30 Official Journal of the European Union EN Member States shall notify the Commission and the other Member States of the national provisions introduced pursuant to this paragraph and the grounds for introducing them. The Commission shall keep the information publicly available.
4.Member States may choose to apply the provisions referred to in paragraph 3 also as regards single-use devices that are reprocessed by an external reprocessor at the request of a health institution, provided that the reprocessed device in its entirety is returned to that health institution and the external reprocessor complies with the requirements referred to in points (a) and (b) of paragraph 3.
5.The Commission shall adopt, in accordance with Article 9(1), the necessary CS referred to in point (b) of paragraph 3 by 26 May 2020. Those CS shall be consistent with the latest scientific evidence and shall address the application of the general requirements on safety and performance laid down in in this Regulation. In the event that those CS are not adopted by 26 May 2020, reprocessing shall be performed in accordance with any relevant harmonised standards and national provisions that cover the aspects outlined in point (b) of paragraph 3. Compliance with CS or, in the absence of CS, with any relevant harmonised standards and national provisions, shall be certified by a notified body.
6.Only single-use devices that have been placed on the market in accordance with this Regulation, or prior to 26 May 2020 in accordance with Directive 93/42/EEC, may be reprocessed.
7.Only reprocessing of single-use devices that is considered safe according to the latest scientific evidence may be carried out.
8.The name and address of the legal or natural person referred to in paragraph 2 and the other relevant information referred to in Section 23 of Annex I shall be indicated on the label and, where applicable, in the instructions for use of the reprocessed device. The name and address of the manufacturer of the original single-use device shall no longer appear on the label, but shall be mentioned in the instructions for use of the reprocessed device.
9.A Member State that permits reprocessing of single-use devices may maintain or introduce national provisions that are stricter than those laid down in this Regulation and which restrict or prohibit, within its territory, the following: (a) the reprocessing of single-use devices and the transfer of single-use devices to another Member State or to a third country with a view to their reprocessing; (b) the making available or further use of reprocessed single-use devices. Member States shall notify the Commission and the other Member States of those national provisions. The Commission shall make such information publicly available.
10.The Commission shall by 27 May 2024 draw up a report on the operation of this Article and submit it to the European Parliament and to the Council. On the basis of that report, the Commission shall, if appropriate, make proposals for amendments to this Regulation.
Vanguard guarantees professional remanufacturing to the highest standard with product-specific validation methods applied in our state-of-the-art production facilities.
1. Collecting used medical devices
Vanguard works in partnership with healthcare facilities to ensure the devices are collected effectively and safely.
We identify, pre-clean, disinfect, decontaminate, laser mark and clearly label all devices collected. Our partner institutions that supplied the used devices are informed about the medical devices that have been received and their status.
This stage includes disassembly, cleaning, disinfection, re-assembly, and 100% product testing for their functionality, including testing the full range of their parameters.
4. Packing sterile goods
The remanufactured products undergo visual checks, final disinfection, machine-applied protective packaging, sterile packaging, before final sealing and inspection of the sealed sterile packaging.
Sterilisation is carried out in accordance with required testing protocols including product inspection and the release of devices only upon completion of a microbiological evaluation.
6. Shipment/delivery of medical devices ready for use
Finally, the sterilised devices are labelled, inserted into external packaging and, following inspection, the medical devices are released for distribution. The packaged devices are then shipped to our customer partners. The products are sorted according to customer specifications, packed in dispatch boxes and handed over to the shipping company.
Advanced Irrigation – irrigation concept for cooled ablation catheters, with irrigation from the proximal to distal end allows the elimination of all residues in the lumen.
End to End Volumetric Monitoring the processing of media flowing through the lumen of each individual medical device and in each process step of the cleaning and disinfection process.
Standardised tests of each electrode for leak-proof integrity and function ensures no leakage of fluids into interior of device and device is free of residues.
Microbiological testing procedure with the reference OPA method according to EN 15883 implemented as standard practice to ensure and document the effectiveness of the cleaning procedure.
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Vanguard Medical Devices Limited
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London WC2A 1LG
BSI Group The Netherlands B.V.
Notified Body CE 0086
Notified Body CE 0481