What information needs to be provided to the Competent Authorities prior to initiation of a clinical study with a product without a CE-Mark or outside of the labelling of a CE-Marked product? What basic information about the medical device needs to be maintained on-file for inspection by the Competent Authorities?
COUNCIL DIRECTIVE 93/42/EEC
STATEMENT CONCERNING DEVICES FOR SPECIAL PURPOSES
1. For custom-made devices or for devices intended for clinical investigations the manufacturer or his authorized representative must draw up the statement containing the information stipulated in Section 2.
2. The statement must contain the following information:
2.1. for custom-made devices: -/-
2.2. for devices intended for the clinical investigations covered by Annex X:
- data allowing identification of the device in question,
- the clinical investigation plan,
- the investigator’s brochure,
- the confirmation of insurance of subjects,
- the documents used to obtain informed consent,
- a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I,
- a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,
- the opinion of the ethics committee concerned and details of the aspects covered by its opinion,
- the name of the medical practitioner or other authorized person and of the institution responsible for the investigations,
- the place, starting date and scheduled duration for the investigations,
- a statement that the device in question conforms to the essential requirements apart from the aspects covered by the investigations and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the patient.
3. The manufacturer must also undertake to keep available for the competent national authorities:
3.1. For custom-made devices, -/-
3.2. For devices intended for clinical investigations, the documentation must contain:
- a general description of the product and its intended use,
- design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,
- the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,
- the results of the risk analysis and a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of this Directive if the standards referred to in Article 5 have not been applied,
- if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,
- if the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the risk management measures in this connection which have been applied to reduce the risk of infection,
- the results of the design calculations, and of the inspections and technical tests carried out, etc.
The manufacturer must take all the measures necessary to ensure that the manufacturing process produces products which are manufactured in accordance with the documentation referred to in the first paragraph of this Section.
The manufacturer must authorise the assessment, or audit where necessary, of the effectiveness of these measures.
4. The information contained in the declarations concerned by this Annex shall be kept for a period of time of at least five years. In the case of implantable devices the period shall be at least 15 years.
5. For custom-made devices, -/-