Both the MDD 92/43/EEC and the MDR 2017/745 allow packages of different products that are combined in a meaningful context for a specific application to be brought onto the market. According to the MDD, these must be CE-marked products. The MDR also allows non-CE marked products, provided their presence is justified within the context of the intended purpose of the unit. In regulatory terminology, these combinations are referred to as “ systems ” and “ treatment units (BE) ” or generically also “sets”. While the MDD does not have a precise definition of the terms, the MDR states that:
Depending on the type of composition and the type of products, such sets are regulated differently. Systems and BEs with and without their own declaration of conformity are known at EU level. Even under the old law, the production of sets according to Article 12 was quite easy to design, with the new freedom provided by the MDR there is even more leeway in the possible combinations. Manufacturers therefore have a large number of possible set combinations which, cleverly combined, documented and discussed, can be legally placed on the market as units even without a separate declaration of conformity for the set. The only limits here are – almost – your own certification and creativity.
But what are the differences between the sets that must be subjected to a conformity assessment by the combiner and those that can be placed on the market without one?
From a simple point of view, systems and BE must always be re-evaluated for their conformity when
The expected highest risk class of a component determines the set class and the corresponding CE marking. For set packing with a declaration of conformity, i.e. sets higher than Class I, certification by a notified body is required.
If medical devices that have already been assessed for conformity are packaged together without changing their intended purpose, no new declaration of conformity needs to be submitted. Without any changes to the product, the existing conformity assessments of the original manufacturer apply. The manufacturer's declaration according to Article 12 MDD or Article 22 MDR is sufficient here, which the set packer must include in his documentation and, if necessary, present during audits. The set packer must be able to prove that the associated tasks have been fulfilled. The set according to Article 12 MDD or Article 22 MDR does not receive a CE mark in its entirety.
Manufacturers of systems and BE must register their activities with the relevant supervisory authorities. In Germany, an entry in the DIMDI database has always had to be made. According to the MDR, system and BE packers have to register as economic actors in EUDAMED.
If you have any questions, TentaConsult Pharma & Med GmbH will be happy to advise you!
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