Documents considered by the Committee on 6 January 2016 - European Scrutiny Contents



Annex: Four blocks for trilogue negotiations

Block 1 consists of Chapter I (Scope), Chapter II (Obligations of economic operators) except Article 15 of the draft Regulation on Medical Devices (Re-processing), Chapter V, section I (Classification), and the related annexes.

Block 2 consists of Chapter III (Identification and traceability), Chapter VI (Clinical evaluation for medical devices and performance evaluation for IVDs), Chapter IX (Confidentiality and data protection), Chapter X (Final provisions, including transitional measures), and the related annexes.

Block 3 consists of IVD-specific issues, notably rules on IVDs for self-testing and genetic testing, as well as classification rules and parts of the provisions on performance evaluation.

Block 4 consists of Chapter IV (Notified bodies), Chapter V, section II (Conformity assessment), Chapter VII (Surveillance of the market), Chapter VIII (Cooperation between Member States, notably the Medical Device Coordination Group), and the related annexes.

The definitions and recitals relating to a specific block were examined together with the enacting terms of that block.


 
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Prepared 15 January 2016