Request for a formal application or request for budget estimate?
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(The budget estimate is a rough estimate of the initial conformity assessment* and will most likely not be identical to the final calculation. The estimate is based on your information in this form. The budget estimate is not considered as an application and will take some time to deliver.) If you opt for a formal application you can ignore queries marked with (1).
*The estimate will explain what’s included in the initial conformity assessment regards to TD assessment and audits. Further future annual costs will also apply to maintain your certification. This is for MDR estimate only and will not cover other standards such as MDSAP.
Basic Company Information
Are you a current Intertek client?
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If yes, please specify for what services Are you a current client of Intertek notified body? (certificate under MDD 93/42/EEC)?
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
MDR code(s) covering your product(s) as part of this applications. Please reference MDR codes according to 2017/2185 and MDCG 2019-14.
*MDCG 2019-13 Guidance on sampling of MDR Class IIa / Class IIb