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CSF: MDD 93/42/EEC Art. 11 (MDR Art. 52) vs. 12 (MDR Art. 22) - Gaining experience and approaching MDR

In March 2017, medical device manufacturers have been faced with the new guidance for ”Own Brand Labeling“ published by the UK Medicines and Healthcare Products Regulatory Agency (MHRA). Consequently most Customized Procedure Tray (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.

What are the consequences under corresponding MDR Art. 22 and 52 which is mandatory starting to May 2020? Get an insight into our experiences by approaching MDR.