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

REGULATION (EU) 2017/745
Medical Devices Regulation

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REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.

Read more: MDR 2017/745 – Medical Device Regulation

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

REGULATION (EU) 2017/746
In-Vitro Diagnostic Device Regulation

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REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU.

Read more: Coming Soon.


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