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 QbD Group?
Benefit from our team of highly qualified consultants. ​
Full support from pre- to the post-marketing phase.​
QbD operates globally, at QbD Austria with a special focus on Europe (EU) and China.​
Constant evaluation, transparency and clear objectives.​
Contact us
Contact us for more information or to request a free, no-obligation proposal.
