Product classification

Medical devices are classified as:

• Class I (non-measuring, non –sterile)
• Class I (Sterile or with measuring function)
• Class IIa
• Class IIb, and
• Class III

For 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.