As a notified body, our company is designated for CE certification of medical devices.
CE conformity assessment of medical devices
According to the current legislation, a medical device may only be placed on the market in the European Union with the CE marking.
All products must meet the essential requirements that apply to them.
Depending on the classification of the product, it may be necessary to use a notified body, i.e. to carry out the CE conformity assessment with an external organization.
Information on conformity assessment procedure
The conformity assessment procedures of CE Certiso Kft. are shown on the following illustrations:

REQUEST
Inquiries are to be sent to our request@cecertiso.hu address!
YES | The manufacturer should decide whether its product is a medical device or not |
YES | Classification procedure (based on MDD, MEDDEV, Borderline Manual and/or involvement of Competent Authority |
CE_mark | Involvement of a designated notified body in the CE conformity assessment procedure (if needed) |
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.
The principal of the EU regulation of medical devices that their use according to the intended purpose and the circumstances do 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 use of the devices shall mean an acceptable risk compared to the patients’ benefits.
CE Certiso Kft. 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). Our designation is valid until 2020.
CE Certiso Kft. can also conduct CE conformity assessment according to EU Regulation 2017/745 (MDR), since 2020.
CE Certiso Kft. performs its conformity assessment activities according to the following regulations:
Our scope:
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.
A list on withdrawn, suspended and forged certificates can be found under the Certificate information menu
The list of our certified clients is available upon request. Please submit your requests in writing to our addresses.