Spotlight

Class I Reusable Surgical Instruments: How are these regulated in the EU?

The EU Medical Device Regulation 2017/745 (MDR) introduces a new sub-classification specifically for reusable surgical instruments which now requires their manufacturers to go down the Notified Body route. Since these devices are still considered to be class I medical devices, they are technically not ‘up-classified’, however, the European Commission felt that such devices needed an increased layer of scrutiny, as had been the case for those devices being provided sterile or having a measuring function.

The EU MDR defines reusable surgical instruments as:

‘Reusable surgical instrument’ means an instrument intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilisation have been carried out.

Annex VIII C1(2.3), EU MDR

If this looks familiar, it’s because this is very similar to how the EU Medical Device Directive 93/42/EEC defined such devices. The new requirement for reusable surgical instruments to seek Notified Body intervention comes specifically from:

Manufacturers of class I devices, other than custom-made or investigational devices, shall declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 19 after drawing up the technical documentation set out in Annexes II and III. If those devices are placed on the market in sterile condition, have a measuring function or are reusable surgical instruments, the manufacturer shall apply the procedures set out in Chapters I and III of Annex IX, or in Part A of Annex XI. However, the involvement of the notified body in those procedures shall be limited:

c)      in the case of reusable surgical instruments, to the aspects relating to the reuse of the device, in particular cleaning, disinfection, sterilization, maintenance and functional testing and the related instructions for use.

Article 52(7), EU MDR

As was the case with sterile and measuring devices under the EU MDD, the involvement of the notified body in the device assessment is limited to those procedures related to the reuse of the device, as mentioned in 7(c) above. Therefore, apart from drawing up the technical documentation in accordance with Annexes II and III of the MDR, the manufacturer must also ensure that the clinical safety and performance of their reusable surgical instruments are not adversely affected by the procedures being used to allow these devices to be reused, namely the cleaning, disinfection, sterilisation, maintenance and functional testing, should these be applicable. As such, notified bodies will be looking for evidence in the form of testing or other documentation which demonstrates that the device will continue to perform as intended, and as safely as intended, after they have been processed. Furthermore, the manufacturer must specify these intended post-use procedures as well as a limit to the number of times the device can be reused.

Manufacturers of reusable surgical instruments under the MDR must ensure that if the device is bearing the Unique Device Identification (UDI) on the device itself, this shall remain visible throughout its intended use and after intended or foreseen reuse procedures have been conducted. Without a doubt, these new requirements will bring about a big change in the reusable surgical instrument industry and meeting these requirements will be quite a burden. The 2nd Corrigendum to the MDR allows an increased grace period for such medical device manufacturers who will now have till 26 May 2024 to comply with these new requirements. Although this will definitely be a cause for relief, we recommend that such manufacturers get in touch with notified bodies and begin transitioning as early as possible.

How we can help #

Specculo provides a wide array of regulatory services to help manufacturers comply with their requirements and obligations in both the EU and UK. Take a look at our services on our Regulatory Consulting page for more information, or get in touch with us today to learn more.

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