MDD 93/42/EEC Article 20 – Confidentiality of Information
Information & Training. | Medical Devices1. Without prejudice to the existing national provisions and practices on medical confidentiality, Member States shall ensure that all the Parties involved in the application of this Directive are bound to observe confidentiality with regard to all information obtained in carrying out their tasks.
This does not affect the obligation of Member States and notified bodies with regard to mutual information and the dissemination of warnings, nor the obligations of the persons concerned to provide information under criminal law.
2. The following information shall not be treated as confidential:
|(a)||information on the registration of persons responsible for placing devices on the market in accordance with Article 14;|
|(b)||information to users sent out by the manufacturer, authorized representative or distributor in relation to a measure according to Article 10(3);|
|(c)||information contained in certificates issued, modified, supplemented, suspended or withdrawn.|
3. The measures designed to amend non-essential elements of this Directive, inter alia by supplementing it, relating to determination of the conditions under which other information may be made publicly available, and in particular for Class IIb and Class III devices to any obligation for manufacturers to prepare and make available a summary of the information and data related to the device, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).
Article 20A – Co-OperationMember States shall take appropriate measures to ensure that the competent authorities of the Member States cooperate with each other and with the Commission and transmit to each other the information necessary to enable this Directive to be applied uniformly.
The Commission shall provide for the organization of an exchange of experience between the competent authorities responsible for market surveillance in order to coordinate the uniform application of this Directive.
Without prejudice to the provisions of this Directive, cooperation may be part of initiatives developed at an international level.
Medical Devices Directive
Information & Training.
- Validation. Classification. Regulation. Requirements. Current best practices.
- FDA cGMP’s. EU MDR’s / MDD’s.
- FDA Medical Device Regulation. Outline of the FDA regulatory requirements.
- FDA Medical Device Classification. The FDA approach to Medical Device Classification.
- EU Medical Device Regulation and Classification (per MDD’s).
- New European Medical Device Regulations (MDR’s). MDR Classification. MDR General Safety requirements.
- Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
- Quality System requirements to maintain compliant Validations.
- Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ.
- Medical Device Software Validation.
- Medical Device Design Validation.
- Electronic Signature, Electronic Records.
- Life Cycle Approach to Validation.
- Risk Identification. Documentation. DHR’s. DMR’s.
- Etc. Etc. …
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