Obelis Attends Inauguration of CURAM (Center for Research in Medical Devices)
News

Obelis Chief Compliance Officer, Mrs. Sandra Ferretti, participated in the official inauguration of CURAM – Center for Research in Medical Devices, which took place on Monday, the 26th of Septemb [...]

MEDDEV 2.7/1 – new guidelines on clinical evaluations
News

On the 29th of June 2016, the European Commission released a new version of MEDDEV 2.7/1, entitled “Clinical Evaluation: A Guide for Manufacturers and Notified Bodies under Directive 93/42/EEC and [...]

EU to release NEW Medical Device Regulations!
News

In June 2016, the European Parliament released the consolidated texts of the new EU Regulation Proposals on Medical Devices and In-Vitro Diagnostics Devices. The texts, published on the European Par [...]

New Medical Devices and In-Vitro Diagnostic Regulations – Status of the Ongoing Discussions
News

The approval of the new EU Regulations on Medical Devices and In-Vitro Diagnostics Devices will be postponed to 2016. (more…) [...]

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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