MDD ARTICLE 19 – Decision in respect of refusal or restrictionMedical Devices Directive – explained >>>
How Medical Devices are regulated in Europe >>>
1. Any decision taken pursuant to this Directive:
|(a)||to refuse or restrict the placing on the market or the putting into service of a device or the carrying out of clinical investigations;|
|(b)||to withdraw devices from the market,|
shall state the exact grounds on which it is based. Such decisions shall be notified without delay to the party concerned, who shall at the same time be informed of the remedies available to him under the national law in force in the Member State in question and of the time limits to which such remedies are subject.
2. In the event of a decision as referred to in paragraph 1, the manufacturer, or his authorized representative shall have an opportunity to put forward his viewpoint in advance, unless such consultation is not possible because of the urgency of the measure to be taken.
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