Compliance

Medical Device Directives

MDD 93/42/EEC
Medical Device Directive

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MDD 93/42/EEC (Medical Device Directive) has been in place since June 14, 1998 and was amended on September 5, 2007. The consolidated directive became mandatory on March 21, 2010. The directive establishes essential requirements and harmonized standards for the manufacture, design, and packaging of medical devices.

Read more: MDD 93/42/EEC – Medical Device Directive

AIMDD 90/385/EEC
Active Implantable Medical Device Directive

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AIMDD (Active Implantable Medical Device Directive) 90/385/EEC has been in place since June 20, 1990. This directive applies to devices according to Article 2.C AIMDD.

Read more: AIMDD 90/385/EEC – Active Implantable Medical Devices Directive

IVDD 98/79/EC
In-Vitro Diagnostic Device Directive

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IVD 98/79/EC (In-Vitro Diagnostic Medical Device Directive) was published on October 7, 1998. It is separate from the Medical Device Directive and contains its own separate set of requirements for manufacturers wishing to place medical devices in the European Economic Area.

Read more: IVDD 98/79/EC – In-Vitro Diagnostic Device Directive


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