The application of MDD regulation 2017/745 is not without consequences for reusable surgical instruments. While it was initally suggested to change their class to IIa, they are finally still classified as class I medical devices.
However, section 7 of article 52 stipulates that reusable surgical instruments are now subject to the intervention of the notified body on the following aspects :
“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.”
The consequences can be substantial for manufacturers that did not anticipate : validation of the cleaning and sterilisation process, definition of the lifetime of the device (maximum number of cleaning and sterilization cycles …), addition of the notified body number on the marking and labelling, verification that the reprocessing has no consequence on the performance and safety of the device …
The validated data shall be added to the instruction for use, as per the essential requirement 23.4 n) :
“If the device is reusable, information on the appropriate processes for allowing reuse, including cleaning, disinfection, packaging and, where appropriate, the validated method of re-sterilisation appropriate to the Member State or Member States in which the device has been placed on the market. Information shall be provided to identify when the device should no longer be reused, e.g. signs of material degradation or the maximum number of allowable reuses.”
Do not hesitate to contact us should you need any support regarding the MDD regulation.