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Specific MDD Procedures
Conformity Assessment Routes under the Medical Device Directive are somewhat different than the conformity assessment procedures for the other EC Directives. Medical Device manufacturers must determine which class their product belongs to and then select the appropriate annexes.
More detailed information
Further Topics
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- The European Union and the EC Directives (an introduction)
- What is CE Marking?
- The Steps to European Conformity
- Harmonized Standards
- The EC Directives
- Evaluation of Conformity
- Status of EC Directives
- Technical File
- Affixing the CE Marking
- Non-Compliance Risk
- Notified Competent Bodies
- CE Marking Services
