Notice

Laboratory

Certification of medical devices

When introduced to the market, medical devices in qualification class I must have an issued Declaration of Conformity, corresponding to the declaration of conformity of other electrical products.
Medical devices in a higher qualification class than I according to the GD 54/2015 Coll. require evaluation by a notified body when introduced to the market.

For an evaluation of conformity by a notified body it is necessary to provide:

  • request for an evaluation of conformity for medical device
  • technical documentation necessary to meet the basic requirements according to annex 1 of the government directive
  • design documentation of the product
  • a risk analysis
  • the results of clinical tests, evaluation, studies
  • the relevant tests of electrical safety and EMC by type of medical device including results
  • minimum requested of the documentation is listed in the requirements for CE certification

 

 

The Active medical (electro-medical)

devices are electric/electro-mechanic

apparatuses whose functioning relies on

electricity or another power source.

They are designed for employment in

diagnosis, treatment, monitoring and healing

of the patient. The employment target for

electro-medical devices, in the healthcare fields of diagnosis therapy and

assistance, for producers implies commitment into granting their safety and

flawless functioning through all necessary testing and trials prior to obtaining brands and labels required in the different markets.

 

What is an active medical device?

An active medical device means any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity and which acts by converting this energy.

The EN 60601 family of standards is of major importance for all electrical active devices for demonstrating compliance with the Essential requirements of the Medical Device Directives.

The classification of medical devices in the European Union is outlined in Annex IX of the Council Directive 93/42/EEC. There are four classes, ranging from low risk to high risk.

  • Class I (including Is & Im)

  • Class IIa

  • Class IIb

  • Class III

The authorization of medical devices is guaranteed by a Declaration of Conformity. This declaration is issued by the manufacturer, but for products in Class Is, Im, IIa, IIb or III, it must be verified by a Certificate of Conformity issued by a Notified Body.

This means whatever type of device a manufacturer wishes to market in Europe, where CE marking is a legal requirement, we have the technical expertise to assist and provide appropriate conformity assessment services.

 

 

 

 

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