Medical Device Directive – 93 42 EEC
MDD ARTICLE 8 – Safeguard clauseMedical Devices Directive – explained >>>
How Medical Devices are regulated in Europe >>>
1. Where a Member State ascertains that the devices referred to in Article 4 (1) and (2) second indent, when correctly installed, maintained and used for their intended purpose, may compromise the health and/or safety of patients, users or, where applicable, other persons, it shall take all appropriate interim measures to withdraw such devices from the market or prohibit or restrict their being placed on the market or put into service. The Member State shall immediately inform the Commission of any such measures, indicating the reasons for its decision and, in particular, whether non-compliance with this Directive is due to:
|(a)||failure to meet the essential requirements referred to in Article 3;|
|(b)||incorrect application of the standards referred to in Article 5, in so far as it is claimed that the standards have been applied;|
|(c)||shortcomings in the standards themselves|
2. The Commission shall enter into consultation with the Parties concerned as soon as possible. Where, after such consultation, the Commission finds that:
|(a)||the measures are justified:|
|(b)||the measures are unjustified, it shall immediately so inform the Member State which took the measures and the manufacturer or his authorised representative.|
3. Where a non-complying device bears the CE marking, the competent Member State shall take appropriate action against whomsoever has affixed the mark and shall inform the Commission and the other Member States thereof.
4. The Commission shall ensure that the Member States are kept informed of the progress and outcome of this procedure.
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 >>>