A product name is not a classification rationale

Under the MDR, classification depends on the intended purpose and the rules in Annex VIII, including factors such as invasiveness, duration of use, active function, implantability and the consequences of an incorrect result. Under the IVDR, classification follows the risk-based rules for Classes A, B, C and D. The current European Commission classification resources are collected in its MDCG guidance register.

What classification changes

• the applicable conformity-assessment procedure;
• whether and how a notified body becomes involved;
• the expected clinical or performance evidence and post-market work;
• the certificates and device scope that must be checked;
• the depth of the EC REP file and liability review;
• the sequence and dependencies of the market-entry project.

Low risk does not mean no verification

For MDR Class I, sterile, measuring and reusable-surgical characteristics can change notified-body involvement. For IVDR Class A, sterile status also matters. A quotation based only on “Class I” or “Class A” may therefore miss a central part of the route.

What to send for a reliable scope

Provide the intended purpose, user and patient population, use environment, duration and mode of contact, operating principle, key claims, current classification, applied rule and a short rationale. Add the proposed device families and current certificates. If classification is not yet confirmed, request a classification review as the first product of work.