More Time for Reusable Surgical Instruments

Given the situation with reusable surgical instruments, it’s clear that Europe, with its transitional provisions, has counted its chickens before they hatched.
Fortunately, albeit in a somewhat grotesque manner due to the reasoning used, it has attempted to remedy this by issuing a corrigendum.

APPLICABLE PROCEDURE (according to Council document R/2521/75):
Procedure 2(c) (obvious errors in all language versions)

Reading the changes, it’s clear that this isn’t a correction of “obvious” errors, but rather a significant change in direction.
In any case, regardless of the polemic note, the content is heartening.

Let’s start from the beginning.
With the new classification rules, some Class I devices are now required to undergo certification by a notified body. We’re particularly talking about reusable surgical instruments.

At the same time, the regulation specifies the possibility to continue placing on the market after May 2020 only devices with a valid certificate according to 93/42/EEC.

Since reusable instruments, being Class I, only require a declaration of conformity drawn up by the manufacturer, they cannot benefit from this transition period. Thus, by May 2020, they should have undergone assessment and certification by a notified body.

It was soon realized that no body would be able to handle such a workload in such a short time, and this, considering the products involved, would have caused problems even more serious than purely economic ones.

Therefore, here’s the European Union’s correction:

[…], a Class I device pursuant to Directive 93/42/EEC, for which a declaration of conformity was drawn up prior to 26 May 2020 and for which the conformity assessment procedure under this Regulation requires the involvement of a notified body, […], may be placed on the market or put into service until 26 May 2024, provided that from 26 May 2020 it continues to comply with either of those Directives, and provided there are no significant changes in the design and intended purpose […]

A truly welcome mea culpa!