MDD / MDR regulation

Hej med jer

Jeg søger lidt hjælp her... 

Hvordan finder man ud af hvordan ens produkt vil blive klassificeret ift. de nye reguleringer der kommer med EU. Er der et opslagsværk som jeg ikke kan finde via. google eller er der nogen der har erfaring med medical?

Jeg søger info omkring "elektrisk næsesuger" 😅

MDD/CE-marking

The Medical Devices Directive 93/42/EEC defines safety and performance requirements for medical equipment sold in the European Union. The requirements apply to both products and manufacturers, generally to all medical devices not covered by the Active Implantable Medical Devices Directive or the IVD Directive (In Vitro Diagnostics).

In order to obtain medical device approval in the EU, medical devices must be correctly classified. The Medical Device Directive defines products into different classes, based on risk and intended use, which determine the relevant conformity assessment procedure in Annex IX. For products classified with medium to high degree of risk (class Is, Im, IIa, IIb and III) the Medical Device Directive requires a conformity assessment procedure involving a notified body.

På forhånd tak.