Compamed Supplier Forum

November 14, 12:45 PM:  MDD 93/42/EEC Art. 11 vs. Art. 12: Consequences for producers of customised procedure trays - Ole Stein, Sales Manager MedNet GmbH
Ole Stein, Sales Manager MedNet GmbH

In March 2017, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance for ”Own Brand Labelling“ of medical devices for medical device manufacturers. Consequently most Customised Procedure Trays (CPT) providers that have been acting according to article 11 MDD conformity assessment procedure are now required to hold a full technical documentation for all products used in a tray. Thus many are changing to article 12 MDD. This means CPT providers are only able to buy CE marked “components”. MedNet presents an efficient solution to kitpackers acting according to article 12 MDD solving the problems of this new procedure.