Reusable Surgical Instruments: Notified Body

It was on May 5, 2017 when the Regulation (EU) 2017/745 officially came to light. After years of hearsay and drafts passed secretly under the table, there it was at last. Everyone started browsing through it with the reassurance that: “it’s talking about the distant 2020 anyway”.

So, imagine I’m a manufacturer of implantable medical devices. I hear about the regulation and, in a moment of interest, I wonder if reusable instruments are still in that wonderful safe haven called Class I.

After a moment of disorientation due to the fact that Annex IX of 93/42/EEC referring to “classification rules” is now Annex VIII, here’s the confirmation:

Rule 6
All surgically invasive devices intended for temporary use are classified as class IIa, unless they are reusable surgical instruments, in which case they are classified as class I.

After a couple of years, word starts to circulate that the term “Reusable surgical instrument” is also used in another article of the regulation:

Article 52 Conformity assessment procedures
If at the time of placing on the market the devices are […] reusable surgical instruments, manufacturers shall apply the procedures set out in Annex IX, Chapters I and III, or in Annex XI, Part A.
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, functional testing and the related instructions for use.

Dismay. The involvement of the notified body?
It is required that even reusable surgical instruments undergo a certification process that involves assessment by a notified body.

In an ideal world, this news should only irritate me, forcing me to ask the body for an additional paid service. Yet I’m mostly worried, and apparently I’m not wrong.

In December 2019, those few bodies with Italian notification for the MDR are unable to offer the required service. The problem is so serious and widespread that some time later, Europe was forced to remedy the situation on the fly.

Why the need for stricter control? Is it for preventive protection given the potential danger of the specific product? Is it due to the delicate nature of its area of use?

The answer is more embarrassing than one might think and is linked to the current presence of potentially dangerous instruments on the market, extremely poor technical documentation – in some cases absent – and reconditioning processes that have, incredibly, never been managed.