Masterstudiengang "Drug Regulatory Affairs"
The European Council's Partial General Approach to the Proposal for a Medical Device Regulation: Its potential implications on demarcation, classification, and conformity assessment of substance-based medical devices ***
Dr. Ruth Zeller-Adam (Abschlußjahr: 2016)
Currently, the European medical device legislation in under complete revision. The official legislative procedure for a Medical Device Regulation (MDR) started in 2012, and now consensus has to be reached in trilogue meetings of EU Commission, Parliament, and Council. The present thesis is based on the situation as per 31 December 2015.
Substance-based medical devices, as an important sub-group of medical devices often regarded as high-risk products by the authorities, are particularly affected by proposed re-classification and specific conformity assessment procedures. In comparison to the classification criteria as set out in Annex IX of Directive 93/42/EEC (MDD), some classification rules are proposed to be modified and new classification rules are introduced in the proposed MDR. Regarding substance-based medical devices, the potential revision of classification rules 3 and 13, and implementation of classification rule 21 (specific rule for certain substance-based medical devices) and even rule 19 on nanomaterials are of special interest.
In addition to the conformity assessment to be performed by a notified body, several specific procedures are foreseen in Council`s Partial General Approach to a MDR involving further parties. Particularly, the implementation of a scrutiny mechanism for certain high-risk devices including class III substance-based medical devices is considered likely, taking into account available information on the ongoing legislative procedure. Moreover, Annex I of Directive 2001/83/EC is referenced for requirements on kinetics, interactions, and toxicity of substance-based medical devices if they are introduced into the human body and they, or their products of metabolism, are systemically absorbed or locally dispersed.
Since the trilogue discussions had not been coming to an end by end of 2015, only preliminary estimations can be given on the content of the future MDR with regard to demarcation, classification, and conformity assessment of substance-based medical devices.