Product Certificate (Medical Devices)

Certification of medical products – our competence:

Within the scope of medical products covered by the following directives implemented into the Polish law:

Medical products:

- Council Directive of 14^th June 1993 on medical devices (93/42/EEC) with amendments

IVD medical devices:

- European Parliament and Council Directive of 27th October 1998 on medical devices for in vitro diagnosis (98/79/EEC) with amendments

Active implantable medical devices:

- Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (90/385/EEC).

WECERT and PCBC are offical partner of National Medical Device Directorate IR. IRAN (IMED) :

in 2018 based on a mutual agreement WECERT and PCBC has been approved by National Medical Device Directorate IR.IRAN (IMED) official partner for issuing ISO 13485:2016 and Medical Device CE Marking.

The scope of Accreditation is according to the following link in IMED Website

Certification Programme

As part of our activities, we certify medical devices based on the following attachments and accreditation area

Directive 93/42/EEC:
• Annex 2 – Full quality assurance system (module H)
• Annex 3 – Type examination (module B)
• Annex 4 – Verification (module F)
• Annex 5 – Production quality assurance (module D)
• Annex 6 – Product quality assurance (module E)

Directive 98/79/EC
• Annex 2 – Full quality assurance system (module H).
• Annex 3 – Type examination (module B)
• Annex 4 – Verification (module F)
• Annex 5 – Production quality assurance (module D)

Directive 90/385/EEC
• Annex 3 – EC Declaration of Conformity (Module A)
• Annex 4 – Full quality assurance system (module H)
• Annex 5 – Type examination (module B)
• Annex 6 – Verification (module F)
• Annex 7 – Ensuring production quality (module D)

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Medical Device Department
Product Certification Department

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