CE

Medical device manufacturers shall ensure that products are complied with Essential Requirements of related applicable Directive prior to marketing in European Economic Area (EEA).

The directives include:

Active Implantable Medical Devices Directive (AIMDD 90/358/EEC).

Medical Device Directive (MDD 93/421EEC).

In Vitro Diagnostic Medical Devices Directive (IVDD 98/79/EC).

Amendment to MDD and IVDD (2007/47/EEC).

Each directive of medical device provides many conformity routes. Manufacturers can select the

appropriate route based on the risk of product.

IVDR MDR

Services

 Product Classification

 Assist you in selecting appropriate conformity route

 Assist you in selecting appropriate notified body

 Recommendation of testing laboratories

 Prepare CE Technical File / Design Dossier

 Assist you in completing clinical evaluation report

 EU Representative Service

Medical Device CE certification consultation