MDR – Article 17 – Single-Use Devices and Their Reprocessing

Post Market Surveillance

With MDR, the reprocessing of single-use devices (MDR Article 17) have also entered our lives. This issue was not previously regulated by the law.

Click here for the full Medical Device Regulation (MDR 2017/745).

Firstly let us explain the meaning of “reprocessing”. You are manufacturing a single use device and you are indicating on IFU that “this device is a single use device and can not be re-used”. But with this regulation, a third party company can now reprocess this device. For example, you are producing a surgical saw blade for orthopedic operations. A health institution is using this saw blade. The sharp teeth of the saw blade are going bad and then third party company is taking this blade from the hospital, sharping it, an proving that sharpen blade is behaving as it is manufactured for the first time.

But we believe that reprocessing causes losing the real performance of the device. Please click here for the article about why single-use devices should not be reprocessed.

Here are the related details with this article:

MDR Article 17 - Single-Use Devices and Their Reprocessing

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.

If your country is one of the member countries of EU, your country should prepare a law to be able to reprocess single use devices. This law must comply with the articles in MDR.

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.

This clause is telling that if you reprocess any single-use device to make it able to re-use it, congratulations, you are the new manufacturer of the device and you are as responsible for this regulation as the actual manufacturer of the device.

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:

  • 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;
  • 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.

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.

As always, there are some exceptions for this article. If you are a health institution, your country may decide not to apply all the rules relating to manufacturers’ obligations. It is sufficient to comply with the sentences indicated with the line above.

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.

This article gives health institutions a special space. If you are a health institution, you can request a reprocessing from a external reprocessor. This reprocessor only needs to comply with the obligations in clause 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 2021 in accordance with Directive 93/42/EEC, may be reprocessed.

Since May 26, 2021 has passed, only devices with MDR certificate can be reprocessed at the moment.

7

Only reprocessing of single-use devices that is considered safe according to the latest scientific evidence may be carried out.

When reprocessing, you have to own the latest scientific proof that you have chosen a safe method.

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.

The name and address of the reprocessor should be written on the label (and on the instructions for use if applicable). You can not write the name of the actual manufacturer of the device on the label but you can indicate it on IFU.

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.

Your country can restrict you in some cases as stated above and shall notify EU Comission about the national law. Comission shall announce this law everybody.

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.

Share This Post :

Twitter
LinkedIn

Related Posts

Products

About

Downloads