Product Classification
Medical devices need to be classified, following a certain set of rules.
We help your to classifiy your product and set up a strategy to obtain CE marking.
Medical devices are classified as:
- Class I (non-measuring, non –sterile)
- Class I (Sterile or with measuring function)
- Class IIa
- Class IIb
- Class III
The medical devices classification is based on a set of 18 rules in accordance with Annex IX of Directive 94/42/EEC (as amended).
All active implantable medical devices fall into class III (Active Implantable Medical Devices Directive (AIMDD) (90/385/EEC).
In Vitro Devices Directive (IVDD) (98/79/EC) are classified according to lists A or B in the annex to the directive.
The highest-risk IVDs are identified in IVDD Annex II. These devices require both design examination and an NB-approved quality assurance system. The IVDs identified in Annex II, List A additionally require NB lot release.
How we support you
- Advise on device classification
- Formulate conformity assessment routes to meet the essential requirements based on device classification
- Formulate a regulatory strategy to achieve CE marking
Why opt for the QbD Group?
EXCEPTIONAL RA SERVICES THAT MEET YOUR NEEDS
10+ years of experience
Benefit from our team of highly qualified consultants.
Full life cycle support
Full support from pre- to the post-marketing phase.
Global presence
QbD operates globally, at QbD Austria with a special focus on Europe (EU) and China.
Customer satisfaction
Constant evaluation, transparency and clear objectives.
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Talk to an expert
Contact us for more information or to request a free, no-obligation proposal.