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Annex II technical documentation assessed.
A W van Drongelen1, B Roszek, E A E van Tienhoven
1Centre for Biological Medicines and Medical Technology, Dutch National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands. arjan.van.drongelen@rivm.nl
Medical Device Technology
|January 20, 2006
Summary
Manufacturers frequently use Annex II of the Medical Device Directive (MDD) for CE-marking. However, this study found significant issues with the technical documentation quality for devices approved via this route.
Area of Science:
- Medical device regulation
- Quality assurance systems
Background:
- Annex II of the Medical Device Directive (MDD) allows manufacturers to gain CE-marking.
- This route bypasses individual device assessment by a Notified Body, relying instead on a full quality assurance system.
Purpose of the Study:
- To investigate the availability and quality of technical documentation for medical devices approved under Annex II of the MDD.
Main Methods:
- Review of technical documentation submitted for devices utilizing Annex II of the MDD.
Main Results:
- Severe shortcomings were identified in the availability of technical documentation.
- Significant quality issues were also found in the existing technical documentation.
Conclusions:
- The current implementation of Annex II procedures presents risks due to inadequate technical documentation.
- Improvements are needed in the oversight and quality control of technical documentation for CE-marking under MDD Annex II.