CL-2022-000676 - [2025] EWHC 2486 (Comm)

Fecha: 01-Oct-2025

Medical devices: MD Directive and MDR 2002

24.

Equally ISO 11137 does not specify any particular quality management system to control all stages of production of medical devices.

25.

The gowns were medical devices regulated by Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (the “MD Directive”), and the Medical Devices Regulations 2002 (“MDR 2002”).

26.

These provided the following structure:

The MD Directive put in place a structure dividing medical devices into categories, of which Category I and IIa are relevant here. The first, Category I, is the most basic level where manufacturers could essentially self certify. Category IIa was a category where the risk profile required higher quality assurance, including “the intervention of a notify body at the production stage” – and where compliance could not be achieved without it.

Regulation 8 MDR 2002 provided that, subject to Regulation 12, no person would place on the market, put into service, or supply a medical device unless it met the essential requirements set out in Annex I to the MD Directive, which provided (section 8.4) that the device must be manufactured and sterilised by an appropriate, validated method;

Regulation 13 referred to Annex V of the MD Directive, which prescribes a system for approval of the quality assurance system for the process for production of relevant medical devices. It involves the provision of information as to the detailed operation of the system, inspection of the operation of the system and the production of a declaration of conformity with the process;

Regulation 10 MDR 2002 provided that no person would place on the market, put into service or supply a sterile medical device unless the device or its sterile pack, sales packaging or instructions bore a “CE mark” that was accompanied by a relevant “notified body number”.

A CE mark was a concept introduced by EC Regulation 765-2008 which covered accreditation of processes. It specifically provided for CE marking “indicating the conformity of a product, is the visible consequence of a whole process comprising conformity assessment in a broad sense.” More specifically “By affixing or having affixed the CE marking, the manufacturer indicates that he takes responsibility for the conformity of the product with all applicable requirements set out in the relevant Community harmonisation legislation providing for its affixing.”

ii)

Pursuant to Regulation 13 MDR 2002, a CE mark could only be applied to a sterile medical device if three conditions were met:

the manufacturer or its authorised representative must have fulfilled the obligations imposed by Annex VII to the MD Directive (reg. 13(1)(a));

the manufacturer or its authorised representative must have issued a declaration of conformity in respect of the relevant medical device in accordance with Annex VII to the MD Directive (reg. 13(1)(b)); and

the manufacturer or its authorised representative must have ensured that the device met the requirements of the MD Directive (reg. 13(1)(c)).

iii)

A “notified body” was a supervising body approved by a local jurisdiction which might be required to certify the processes at different stages. So for particularly high risk devices notified body certification needed to cover design and manufacture; for medium risk it was required for manufacture only, whereas for lower risk (non-sterile) items no notified body was necessary – manufacturers could self certify. For sterilised products however the notified body needed to certify the procedure leading to the obtaining of sterility until the sterile package is opened.