Terms & conditions - contracts - processes
Terms & conditions
Process descriptions
- Certification of Quality Systems
- Certification of OEM Devices
- Technical Cooperation Programme – Taiwan
- Cooperation Procedure for Approvals in Ukraine
Regulations for the certification
- Rules for certification procedures for MDR 2017/745
- Rules for certification procedures according to Regulation (EU) 2017/746 (ID 5672)
Applications and certification contracts
- Power of Attorney
- Application for Certification for QM Standards
- Application for Certification for MDR 2017/745
- Application of Surveillance of Legacy Devices according to Regulation (EU) 2017/745 Article 120
- Application for Certification for IVDR 2017/746
- Application for lot inspection for IVDD 98/79/EC