The European Union Medical Device Regulations (EU MDR) (2017/745) introduce new requirements for Reusable Surgical Instruments. The EU MDR requires that aspects of reuse of Reusable Surgical Instruments are subject to conformity assessment by Notified Bodies.

Reusable Surgical Instruments are defined as “instruments 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 sterilization have been carried out.” (Annex VIII, Chapter 1, 2.3).

To be marketed after May 25, 2020, these devices must bear the CE mark along with the notified body number of the notified body issuing the CE mark.

This requirement is based on the following Articles in the EU MDR:

  • Article 20.1, 20.3, 20.4 and 20.5
  • Article 52 (7c)

 

Article 52 identifies devices to which conformity assessment procedures are applicable. Per Article 52(7c) conformity assessment procedures apply to reusable surgical instruments for aspects related to reuse (in particular cleaning, disinfection, sterilization, maintenance and functional testing and the related instructions for use). See below:

Article 52
  • 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:
  • 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 20 identifies which devices require CE marking and notified body identification. Devices that are regulated by the MDR regulations and are in conformity are required to bear a CE mark. The CE mark must be affixed to the device unless it is not possible due to device size or nature of the device, in which case it can be on the packaging.  Lastly, if conformity assessment procedures (per Article 52) are applicable, then the notified body identification is also required to be included. See below:

Article 20
  1. Devices, other than custom-made or investigational devices, considered to be in conformity with the requirements of this Regulation shall bear the CE marking of conformity, as presented in Annex V.
  2. The CE marking shall be affixed visibly, legibly and indelibly to the device or its sterile packaging. Where such affixing is not possible or not warranted on account of the nature of the device, the CE marking shall be affixed to the packaging. The CE marking shall also appear in any instructions for use and on any sales packaging.
  3. The CE marking shall be affixed before the device is placed on the market. It may be followed by a pictogram or any other mark indicating a special risk or use.
  4. Where applicable, the CE marking shall be followed by the identification number of the notified body responsible for the conformity assessment procedures set out in Article 52. The identification number shall also be indicated in any promotional material which mentions that a device fulfills the requirements for CE marking.

 

In summary, manufacturers of Reusable Surgical Instruments should:
  • Develop and maintain a Technical File.
  • Apply appropriate Conformity Assessment Procedures (Chapters I and III of Annex IX, or in Part A of Annex XI).
  • Issue a Declaration of Conformity.
  • Affix the CE mark and notified body number.

 

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