European Medical Device Directive
MDD ARTICLE 4
Free Movement – Medical Devices intended for Special PurposesMedical Devices Directive – explained >>>
How Medical Devices are regulated in Europe >>>
1. Member States shall not create any obstacle to the placing on the market or the putting into service within their territory of devices bearing the CE marking provided for in Article 17 which indicate that they have been the subject of an assessment of their conformity in accordance with the provisions of Article 11.
2. Member States shall not create any obstacle to:
|—||devices intended for clinical investigation being made available to medical practitioners or authorized persons for that purpose if they meet the conditions laid down in Article 15 and in Annex VIII,|
|—||custom-made devices being placed on the market and put into service if they meet the conditions laid down in Article 11 in combination with Annex VIII; Class IIa, IIb and III devices shall be accompanied by the statement referred to in Annex VIII, which shall be available to the particular patient identified by name, an acronym or a numerical code.|
3. At trade fairs, exhibitions, demonstrations, etc. Member States shall not create any obstacle to the showing of devices which do not conform to this Directive, provided that a visible sign clearly indicates that such devices cannot be marketed or put into service until they have been made to comply.
4. Member States may require the information, which must be made available to the user and the patient in accordance with Annex I, point 13, to be in their national language(s) or in another Community language, when a device reaches the final user, regardless of whether it is for professional or other use.
5. Where the devices are subject to other Directives concerning other aspects and which also provide for the affixing of the CE marking, the latter shall indicate that the devices also fulfil the provisions of the other Directives.
However, should one or more of these directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the CE marking shall indicate that the devices fulfil the provisions only of those directives applied by the manufacturer. In this case, the particulars of these directives, as published in the Official Journal of the European Communities, must be given in the documents, notices or instructions required by the directives and accompanying such devices.
Medical Device Validation – Regulation. Requirements & current best Practices.
- How to plan and implement a Validation program.
- How to identify Validation requirements versus actual status.
- The Life Cycle approach to Validation.
- How to identify Validation Gaps and confirm Validation effectivity.
- Reporting on the outcomes of Validations performed.
- Use to develop your personal understanding.
- Use as a support if providing training.
- Details >>>