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What is the role of the Notified Body?

A Notified Body is an organization that assess whether manufacturers and their medical devices meet the requirements of the relevant EU Directives. Notified Bodies for medical devices conduct conformity assessments to ensure medical devices meet the requirements set out in the legislation. Upon successful completion of the appropriate assessments, the Notified Body will issue relevant certification allowing manufacturers to apply the CE- Marks on their product and place them in the EU market.

Medical Device Directive MDD93/42/EEC

The Medical Device Directive was published in 1993 by the European Commission. In June 1998, the Directive became mandatory and medical devices, which fell under the scope of the Medical Device Directive, were no longer allowed without the CE mark on the European market.

To download the latest consolidated MDD93/42 EEC, click here

In Vitro Diagnostic Medical Device Directive 98/79/EC

The IVD Directive was published in 1998 by the European Commission. The directive became mandatory on June 7, 2000. The IVD Directive was amended and corrected over time.

To download the latest consolidated IVDD 98/79/EC, click here 

Active Implantable Medical Deivce Directive AIMDD 90/385/EEC

The Active Implantable Medical Device Directive (AIMDD) was published in 1990 by the European Commission. The diective became applicable on January 1, 1993 with a transitional period until December 31, 1994. The AIMDD Directive became corrected and amended over time.

To download the latest consolidated AIMDD 90/385/EEC, click here