suncitygroup太阳新城(中国)集团官方网站

Eu MDD certification approach

According to the provisions of MDD, there are many ways to choose the CE certification, but in the actual operation, usually the following way: I common: DoC(conformity declaration)+CE technical documents, such products do not need to announce the participation of institutions, enterprises can declare their compliance, Europe will be registered in the EU after the product can be sold.

Is, Im, IIa: EN ISO 13485 (may not include design and development) +CE technical documentation review.

IIb: EN ISO 13485(must include design and development)+CE technical documentation review.

III: EN ISO 13485(must include design and development)+ design review +CE technical document review.

Scope of MDD instruction

The MDD directive applies to some medical devices marketed in all EU member States and some non-EU countries. Partial medical device means any instrument, device, appliance or other thing intended for use in the human body, whether alone or in combination, including the software required for its normal use:

(1) Diagnosis, prevention, surveillance, treatment or mitigation of diseases;

(2) diagnosis, monitoring, treatment, mitigation or repair of injury or disability;

(3) exploration, replacement or alteration of anatomical and physiological processes;

(4) Control of pregnancy. But not all medical devices are subject to MDD directives.

Eu MDD certification approach

Scope of MDD instruction

International Projects

China Project

About Us

Database

400-0569-812

Database

400-0569-812