![]() ![]() 3 Clinical investigations: serious adverse reporting under Directives 90/385/EEC and 93/42/EC – SAE reporting form 2 Guidelines for competent authorities for making a validation/assessment of a clinical investigation application under Directives 90/385/EEC and 93/42/EC 4 Clinical evaluation: Guide for manufacturers and notified bodiesĪppendix 1: Clinical evaluation on coronary stents MEDDEV 2.5/10 Guideline for authorised representatives Incorporating products containing natural rubber latex 1 Conformity assessment of breast implants 1 Homogenous batches (verification of manufacturers’ products) GHTF-Part 5: Audits of Manufacturer Control of Supplies ![]() Regulatory auditing of quality systems od medical device manufacturers. MEDDEV 2.2/4 Conformity assessment of in vitro fertilisation (IVF) and assisted reproduction technologies (ART) products MEDDEV 2.1/6 Qualification and classification of stand alone software MEDDEV 2.1/5 Medical devices with a measuring function MEDDEV 2.1/4 Interface with other directives – Medical devices Directive 89/336/EEC relating to electromagnetic compatibility and Directive 89/686/EEC relating to personal protective equipmentįor the relation between the MDD and Directive 89/686/EEC concerning personal protective equipment, please see the Commission services Interpretative document of 21 August 2009 3 Borderline products, drug-delivery products and medical devices incorporating, as integral part, an ancillary medicinal substance or an ancillary human blood derivative MEDDEV 2.1/2.1 Treatment of computers used to program implantable pulse generators 2 Field of application of directive ‘active implantable medical devices’ MEDDEV 2.1/1 Definitions of ‘medical devices’, ‘accessory’ and ‘manufacturer’
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