Amendments to Annex II, and derogation clause
Article 14
1
Where a Member State considers that:
a
the list of devices in Annex II should be amended or extended; or
b
the conformity of a device or category of devices should be established, by way of derogation from the provisions of Article 9, by applying one or more given procedures taken from amongst those referred to in Article 9,
it shall submit a duly substantiated request to the Commission and ask it to take the necessary measures.
Where those measures concern matters referred to in point (a), designed to amend non-essential elements of this Directive, they shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).
Where those measures concern matters referred to in point (b), they shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).
2
When a measure is to be taken in accordance with paragraph 1, due consideration shall be given to:
a
any relevant information available from the vigilance procedures and from external quality assessment schemes as referred to in Article 11;
b
the following criteria:
1. whether total reliance has to be placed on the result obtained with a given device, this result having a direct impact on subsequent medical action, and
2. whether action taken on the basis of an incorrect result obtained using a given device could prove to be hazardous to the patient, to a third party or to the public, in particular as a consequence of false positive or false negative results, and
3. whether the involvement of a notified body would be conducive to establishing the conformity of the device.
3
The Commission shall inform the Member States of the measures taken and, where appropriate, publish these measures in the Official Journal of the European Communities.
Substituted by Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny Adaptation to the regulatory procedure with scrutiny — Part Four.