CE CERTIFICATION
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:
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:
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
CE conformity assessment (EU) Regulation 2017/745 (MDR)
- Comission Implementing Regulation (EU) 2017/2185
Our scope:
- MDD: Annex II., V. and VI.
- AIMD: Annex II. and V – – Active implantable medical devices for stimulation / inhibition and for horizontal codes
Horizontal competencies: devices containing pharmaceutical substances, sterile devices, devices with biological active coating or component and devices with software
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
MDR: (EU) Regulation 2017/745 Annex I., II. and A
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.
The list of our certified clients is available upon request. Please submit your requests in writing to our addresses.
GDPR
CE CERTISO KFT:
H-2092 Budakeszi, Erdő utca 101.
+36 23 880 830
H-2092 Budakeszi, Pf:70.
info@cecertiso.hu