
CE MARK PROGRAMME
CE marking is a declaration by the manufacturer that a product satisfies appropriate provisions of the relevant legislation in Europe. The CE marking demonstrates that a manufacturer has implemented appropriate European Regulation and Directives and the relevant authorities have authorised access to the European market.
For medical devices whether your business is a large blue-chip organisation, SME or start-up company, QFI can guide and assist with the many steps to attain CE Marking whereby we can assist in numerous ways notably:
- Medical device classification
- Appropriate Notified Body selection
- Communication with Competent Authority where necessary
- Essential Requirements Compliance
- Identify applicable harmonised standards and help ensure conformity with them
- Support implementing and maintaining ISO 13485 and ISO 9001 quality systems
- Construct labelling, packaging, brochure and Instructions for Use
- Conduct hazard evaluations, risk assessment and management
- Performance evaluation design and management
- Clinical investigation design and management
- Vigilance Procedure and Post Market Surveillance development and execution
- Produce Design Dossiers where necessary
- Act as an Authorised Representative
- Improve and compile the entire CE Technical file
- Expedite submissions to the relevant authorities
- Register medical devices with the appropriate Competent Authority
- Provide on-site regulatory support during Conformity Assessment by Notified Bodies including EC design-examination
- Cardiovascular devices
- Orthopaedic devices
- Active and non-active implantable devices
- TSE and animal tissue-derived products
- Medical-electrical devices
- Devices containing radioactive material
- Borderline devices
- Nanotechnology devices
- Wireless devices
- Medical device software including stand-alone and Cloud
- Bluetooth devices
- In vitro diagnostic products
- Drug-device combination products
- Wound healing products
- Continence devices
- Regenerative medicine
- Breast implants
- Personal protective equipment
- Cosmetic products
- Other permanent implants
- Cognitive psychology