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.
Announcement of changes by the manufacturer to the certificate HERE.
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
Process of conformity assessment of Medical Devices
The conformity assessment process includes the following steps:
Evaluation of the conformity assessment application
With the application EZÚ should receive the technical documentation and clinical file. The contents of the documentation are in the Requirements for CE certification – EN.
The attached list is a general guidance and the file contents will vary according to character and intended use of the medical device. The attached list should be sent to EZÚ filled with remarks where to find respective parts of the documentation (e.g. page nr. or chapter Nr.). In order to keep the process easy, the requestor should preferably arrange the chapters of his documentation according to the list.
The submitted documentation should be prepared according to Medical Device Directive 93/42/EEC, 90/385/EEC and other relevant documents (MEDDEVs, ISO standards etc.).
Assessment of technical documentation and clinical testing
After the application is accepted and contract is signed, the assessment of the technical file/design dossier and the assessment of the clinical file starts. If needed, also laboratory tests of the product samples are started (e.g. electrical safety, electromagnetic compatibility etc).
During the assessment process, EZU might ask additional documents or clarifying questions
In case that each part of the process is closed with positive result, an on-site audit of the manufacturing and possibly also of suppliers of critical components or services is performed.
The audit length is depending on the size of the audited site (on number of employees), number of submitted applications and number and importance of critical components and/or critical services suppliers.
Issuance of the certificate
The CE certificate will be issued based on recommendations of the assessors and auditors. The issuance of the certificate is reported to the European database EUDAMED. This also means, if a notified body has to refuse to issue a certificate, it has also to be reported.
The whole process of certification depends on quality of documentation. In case the Competent Authority has to be asked for statement or opinion (e.g. when the medical device contains a medicinal substance as integral part or when the device is a borderline product etc.), the time of the assessment process shall be extended according to the response time of the competent authority.
If there are substantial parts of the documentation missing or are extremely brief, unclear, not understandable etc., so that the requestor cannot proof the conformity with the requirements, he is usually asked to re-send a completed documentation again. If after this step the submitted documentation is obviously still not sufficient to proof the conformity, EZÚ might refuse the issuance of the certificate with the consequences mentioned above.
EZÚ accepts documentation in following languages: Czech, Slovak and English.
The submission of documentation (or parts of it) in other languages (e.g. German) could be possible but has to be agreed at the beginning of the process.
The Government Directive no. 54/2015 Coll. – the Council Directive 93/42/EEC, 2007/47/EC for medical devices
The Government Directive no. 481/2012 Coll. on the restriction of the use of certain hazardous substances in electric and electronic equipment.
Certification of quality systems in accordance with the ČSN EN ISO 13485:2012 standard.
- Performance of tests electrical safety, electromagnetic compatibility, RoHS
- Exposure test reports
- Issuance of certificate EZU
- The assessment of technical documentation
- Certificate system certification referred to in Annexes government regulations and standards ČSN EN ISO 13485:2016
- Active implantable medical devices – Annex2, 5.
- Active medical devices – Annex2, 5.
- Inactive medical devices – Annex2, 5.
- Inactive implantable medical devices – Annex 2, 5.
- Test of enviromental effects, IP ingress protection, noise, vibration
- Mechanical tests
- ESC license
- CB certificate