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Medical Device Directive

MEDICAL DEVICE DIRECTIVE ( 93/42/EEC )

 

As from 26 May 2021, the notified bodies designated under Directive 93/42/EEC as listed here are no longer able to issue new certificates under that Directive, but only allowed to carry out surveillance activities for certificates validly issued under that Directive in the transitional period, as established in Article 120 of Regulation (EU) 2017/745.

 

Application Forms:

 

- Technical File Amendment Form  

 

 

Certified body can be searched from Basic Search web page ( https://basvuruportal.tse.org.tr/Genel/FirmaArama.aspx)   with company name or certificate number.

 

Our Scope for 93/42/EEC Medical Device Directive:    https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=289290&version_no=17 

 

Please communicate with us for your questions and our fees.

Certification Program

 

Tel:  90 - 312 416 64 61     

Fax: 90 - 312 416 6282

mdd@tse.org.tr

 

 

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