Classification of a Sterile Procedure Pack

#1
Hi all,

We are manufacturers of Single-use sterile procedure packs, CE marked for sterility under MDD 93/42/EEC. All components (devices within the procedure pack) are readily available over-the-counter devices that each bear their own CE mark and range from class I up to IIa. All components are used within their intended purpose.

I have always been in the view that our products are on the market as class Is. However, I have since been told that the procedure packs should be classified as the highest class component within the procedure pack - i.e. IIa

I have referenced MEDDEV 2.4/1 Rev 9 section 3.1 - which states the IIa classification would only be in effect if the components do not bear their own CE mark or are intended to be used outside of their intended use.

We will be moving to MDR 2017/745 soon and wish to receive clarification on this issue before the Tech File is updated.
 
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