Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Experiment Videos

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
PubMed
Summary
This summary is machine-generated.

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Stimulation frequency history alters length-force characteristics of fully recruited rat muscle.

Journal of electromyography and kinesiology : official journal of the International Society of Electrophysiological Kinesiology·2010
Same author

The kinetics of the tissue distribution of silver nanoparticles of different sizes.

Biomaterials·2010
Same author

In vitro and in vivo (cyto)toxicity assays using PVC and LDPE as model materials.

Journal of biomedical materials research. Part A·2006
Same author

Improvement of steam sterilization.

Tropical doctor·2003
Same author

Medical devices manufactured from latex: European regulatory initiatives.

Methods (San Diego, Calif.)·2002
Same author

Study to determine the presence of antipolymer antibodies in a group of Dutch women with a silicone breast implant.

Clinical and experimental rheumatology·2002
Same journal

Safer arterial access.

Medical device technology·2010
Same journal

Building better surfaces.

Medical device technology·2010
Same journal

PVC: a broader perspective.

Medical device technology·2010
Same journal

Joining and forming using torsional ultrasonic principles.

Medical device technology·2010
Same journal

US regulation of combination products.

Medical device technology·2010
Same journal

Assessing biological safety of metals associated with medical devices.

Medical device technology·2010
See all related articles

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.

Related Experiment Videos

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.