Pre-application form for MDR 2017/745 certification at Intertek Medical Notified Body

Please complete the form below and submit to enter your pre-application for MDR 2017/745 certification.

MDCG_2019_14_Explanatory note on MDR codes

Please provide the name and contact information of the person to whom all correspondence should be addressed

 

 

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What other certification services are you interested in?

ISO 13485, EN ISO 13485
MDSAP
Other services provided by Intertek

If other...

Basic Company Information

Are you a current Intertek client?

(Select from below...) Yes No

If yes, please specify for what services

Are you a current client of Intertek notified body? (certificate under MDD 93/42/EEC)?

Please select... Yes No

Specify number of sites (manufacturing site, head office, etc.) as part of this application. More then 4 sites will not be reflected in the budget estimate.

How many Full Time Equivalent (FTE) will be involved, at ALL sites, by the potential certification under MDR?

Basic Product Information

(We cannot under any circumstance guide, support or consult you in acquiring the information below since it is the responsibility of you as a manufacturer to understand the regulation.)

Is the device(s) concerning this application a medical device per definition in Article 2, (1) of 2017/745 MDR?

Please select Yes or No Yes No

MDR code(s) covering your product(s) as part of this applications. Please reference MDR codes according to 2017/2185 and MDCG 2019-14.

Your estimated number of Technical Documentation Files (TDF) for class III.

Your estimated number of generic device groups (EMDN level 4) for class IIb*

Your estimated number of device categories (NBOG codes) for class IIa*

*MDCG 2019-13 Guidance on sampling of MDR Class IIa / Class IIb

Form Version 2020-03-18