As a notified body, our company is designated for CE certification of medical devices.

The principal of the EU regulation of medical devices that their use according to the intended purpose and the circumstances does not endanger neither the patients’ health and safety, nor the safety of the users or other people. It is a criterion that any danger in connection with the us of the devices shall mean an acceptable risk compared to the patients’ benefits.

CE conformity assessment of medical devices

E Certiso Ltd. has been specialized on CE certification of medical devices. Our company has been designated for conformity assessment activity according to Directive 93/42/EEC on Medical Devices (MDD), Directive 90/385/EEC on Active Implantable Medical Devices (AIMD) as well as Directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVDD).

CE Certiso Ltd. as one one of the notified bodies in field of medical devices offers CE certification for medical devices.

REQUEST

Request form for CE certification (.doc)
Request form for CE certification (.odt)
Request form for Design examination certification (.doc)
Request form for Design examination certification (.odt)

It is the manufacturer’s responsibility at all times to decide whether a device is a medical device or not and to class them. The classification decides the conformity assessment of the product, i.e. which the procedure to apply for acquiring the CE mark.

CE Certiso Ltd. performs its conformity assessment activities according to the following regulations:

  • 315/2009. (XII. 28.) Decree of the Government on notification of organizations attending conformity assessment and about detailed rules of the notified organizations’ activity

  • 18/2010. (IV. 20.) Decree of the Minister of Health on special rules of notification of those organizations attending conformity assessment and seized of the distribution requirements, which are in the regulatory competence of the Minister of Health, and of the notified organizations’ activity

  • 4/2009. (III. 17.) Decree of the Minister of Health on medical devices

  • 8/2003. (III. 13) Decree of the Minister of Health, Social and Family Affairs on in vitro diagnostic medical devices

Scopes

  • MDD: our scope can be found on NANDO website

  • AIMDD: our company is designated for AIMD 0101 – Active implantable medical devices for stimulation / inhibition and for horizontal codes

  • IVDD: according to Annex IV and VII CE Certiso Ltd. (NB 2409) is entitled to perform conformity assessment of the following devices: Tumoral marker: PSA, Risk of trisomy 21 (including software), Device for self-diagnosis: device for the measurement of blood sugar, and according to Annex III, IV and VII we are entitled to perform the CE certification of the following devices: Clinical chemistry, Pregnancy and ovulation and Specimen receptacles.

  • Horizontal competencies (sterile and biological active coating) are covered as well.

The classification of a product is the responsibility of the manufacturer. There are several borderline issues: according to the regulation, the competent authority, in Hungary the Department for Medical Devices of National Institute of Pharmacy and Nutrition (OGYÉI) is authorised to give an expert report on whether a product can be considered a medical device or not and on classification questions as well.

Information on the conformity assessment procedure

Conformity assessment procedure of CE Certiso Ltd according the relevant Annex of the relevant Directive is shown by the following diagrams:

Initial conformity assessment procedure
Surveillance conformity assessment procedure
Renewal conformity assessment procedure

Our request form can be found HERE. Medical devices incorporating medicinal substances, according to Directive 2001/83/EC are covered as well, just as Medical devices utilising biological active coatings and/or materials or being wholly or mainly absorbed or sterile devices.

The list of our certified clients is available upon request. Please submit your requests at our addesses.