Medical Device Testing

Medical Device Testing

To be placed on the European market, medical devices first have to be submitted to the CE marking process.

This CE marking means that the device complies with the requirements of all applicable Directives.

The main requirements for safety and performance that are applicable to the medical devices (MD) are defined in the 93/42/EEC Directive (amended in 2007).

However, Medical Devices also have to comply with another Directives:

  • Directive 90/385/EEC applicable to Active Implantables Medical Devices (AIMD),
  • Directive 98/79/EEC applicable to In Vitro Diagnostic Medical Devices, (IVDMD),
  • RED Directive (2014/53/EU), applicable to Medical Devices fitted with radio module,
  • ROHS Directive (2011/65/EU), already applicable to some Medical Devices.

The Directive 93/42/ECC defines 4 classes for the Medical Devices (I, IIa, IIb and III), according to the risk related to the technological characteristics of the devices and to the way they will be assessed. The higher the class of the device is, the more strengthened the rules of evaluation and of control will be.

In all cases, the company in charge of placing the MD on the market must both:

  • Develop the technical file and keep it up to date (including safety test reports)
  • Develop the compulsory procedures and keep them up to date, or even obtain ISO 13485 certification related to the Quality Management System.

 

Curtis-Straus services in the medical sector :

Our Scope

Being accredited for a set of electromedical standards, Curtis-Straus offers their expertise to manufacturers, retailers and importers of electromedical devices. LCIE Bureau Veritas is an active member of standardization commissions (UTE).

Through the Bureau Veritas worldwide network of laboratories we offer you an international set of services.

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