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MAGYAR

Certification of medical devices and compliance audit according to 93/42/EEC directive

About medical devices

Definition of medical device according to relevant law:

‘Medical device’ means any instrument, apparatus, appliance, material or other article, alone or in combination, software, custom-made and made for clinical investigation, intended by the manufacturer to be used, for human beings for one or more of the following specific medical purposes:

aa) diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,

ab) diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,

ac) investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,

ad) devices for control of conception

and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.

b) device made with non-viable animal-derived tissue or cells

c) device is intended to administer a medicinal product

d) device incorporates a substance which, if used separately, may be considered to be a medicinal product which is liable to act upon the body with action ancillary to that of the device

e) device incorporates human blood or plasma products which, if used separately, may be considered to be a medicinal product which is liable to act upon the body with action ancillary to that of the device

As other directives are concerned for some groups of medical devices, therefore it is necessary to take into consideration the following:

  • IVD devices: 98/79/EC
  • Active implantable devices: 90/385/EEC
  • Medicinal products: 65/65/EEC
  • Cosmetic products: 76/768/EEC
  • Devices incorporating human blood, blood product, plasma or blood-cell: 2000/70/EC
  • Human transplantatum, tissues or cells or products containing human tissues, cells or derived from them
  • Devices containing animal tissues, but tissues which has become or made non-viable: 2003/32/EC
  • Medical devices, containing medicinal product: 2001/83/EC
  • 93/42/EEC directive does not refer to personal protective equipment, 89/686/EEC refers to them

In deciding which directive refers to the given medical device, its intended use is decisive. Primary intended use of medical devices is health care. There are a lot of instruments, which is thought to be a medical device, but according to the definition it isn’t. In this case the deciding factor is, what its intended use was according to the manufacturer, and does it meet the definition above.

 

Classification of medical devices

After manufacturer has decided whether product is medical device, it has to be classified for judging what kind of compliance audit is needed.

93/42/EEC directive classifies medical devices into four classes:

I.low risk grade products

II.a medium risk grade products

II.b medium risk grade products

III.high risk grade products

Manufacturer / European authorized representative (EC REP) has to classify devices according to annex 9. 93/42/EEC and prior to classification has to realize expressions, implementing rules and definitions.

Manufacturer / European authorized representative can choose the suitable certification process after classification, for which annex 9. chapter III. 93/42/EEC “About classification process” can be used as guide.

CE marking

If manufacturer wants to market its medical device in the European Union, it must have CE marking.

Official definition of CE marking is as follows:

By affixing the CE marking to a product, a manufacturer declares that the product meets all the concerned requirements and legal requirements for CE marking and can be sold throughout the EEA.

Device can be marketed only if it meets the basic requirements of concerned directions.

CE marking is requirements for admission to European market, thus if manufacturer would like to market its product within the EU, it must possess CE marking. CE marking assures, that conformity of product is proven with conformity assessment procedures which investigates conformity of basic requirements of concerning directions, but it is not directly means that product has been manufactured within the European Economic Area.

It is always manufacturer’s responsibility to perform conformity assessment procedure, fill out Declaration of Conformity and place CE marking on product.

Conformity assessment procedure (MD)

After successful closing of conformity assessment procedure and filling out Declaration of Conformity, manufacturer can place CE marking on the product. Manufacturer holds all the responsibilities for conformity of product and authenticity of CE marking.

Last updated: 2017.10.16 17:38