Medical Device Directive 93/42/EEC Annex VII, Risk Class I compilation of the CE Mark Technical File
Systematic consulting delivery starts with an experienced regulatory affairs consultant explaining the detailed compliance project plan based on the Annex VII of the medical device directive to be implemented with their guidance by phone and emails.
What Manufacturers Need To Know and Do When CE Marking Medical Devices|
Customized guidance packages typically consist of templates, information, examples, checklists and forms and are delivered via email for the client with consultants assistance in such a sequence that repetition is eliminated and documentation is kept to a minimum.
Example of a typical guidance package addressing:
- Risk Classification: rationale document prepared by consultant and completed and confirmed by manufacturer.
- Document organizing the devices into product categories and groups based on an EU harmonized standard prepared by consultant and completed by the manufacturer for each technical file. Template is provided.
- Listing the device manufacturers suppliers and other third parties, defining the services and components they provide to the manufacturer, with copies of quality management certificates where available. Template is provided.
- EU States and languages:Identifying the EU states where the device(s) will be sold. Manufacturer to arrange for translations of required documentation. List of translation companies is provided.
- Product Description and technical information:includes description and intended use; model numbers and accessories, explanation of manufacturing process, design configuration and packaging information, etc.
- System Quality:Risk Class I devices do not require an ISO 13485 quality management system but do require several procedures, i.e. translation, post production, traceability and vigilance procedures. Templates are provided in accordance with EU Meddev guidelines and consultant assistance.
- Labeling and instructions for use:Checklists based on several EU harmonized standards including EU symbols, are provided to ensure European compliance and are reviewed by the QNET LLC consultant. Compliant label and IFU to result.
- Risk analysis:Completing and documenting of a device Risk Analysis in accordance with EU harmonized standard ISO 14971. A guidance form is provided by QNET LLC to ease the completion effort with this top level document with the assistance of the consultant.
- Essential Requirements:detailed compliance focusing on the safety of patients and professionals. A guidance form to ease the completion of the top level document is provided. The consultant assists with identifying applicable EU harmonized standards and determining whether or not any testing is required. Test results to be added to the technical file.
- GMDN Code explanation and instructions where to purchase.
- Clinical evaluation:Risk Class I devices do not require a clinical study. Instead they require a clinical evaluation based on a compilation of existing EU standards, literature search, experience and manufacturers data. QNET LLC provided a guidance form to ease completion with consultant's assistance.
- Declaration of conformity:QNET LLC drafts a Declaration of Conformity for manufacturers approval and acceptance.
- Deliverable:Medical Device Directive 93/42/EEC, Annex II Technical File
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