Menu Close

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

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

Why opt for the QbD Group?


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.

Contact us

Talk to an expert

Contact us for more information or to request a free, no-obligation proposal.