Single chamber, extravascular implantable cardioverterdefibrillator (ICD)
This page lists all published expert decisions and opinions in the context of the Clinical Evaluation Consultation Procedure (CECP) according to Article 54 of Regulation (EU) 2017/745).
The consultation procedure might be relevant to you, if you are a manufacturer of one of the following devices (exceptions, see Article 54 (2) MDR):
(a) class III implantable devices, or
(b) class IIb active devices intended to administer and/or remove a medicinal product, as referred to in Section 6.4 of Annex VIII (Rule 12).
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