The Medical Devices Introductory Course 2020

• EU certificates are issued by NBs for: Annex IX Ch I EU QMS Annex IX Ch II Certificates Article 56 and Annex XII

EU Technical Documentation Assessment

Annex X EU Type-examination Annex XI, Part A EU Quality Assurance Annex XI, Part B EU Product Verification

• Certificates are normally valid for 5 years • Certificates may be extended based on a re-assessment

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

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Declaration of Conformity Article 19, Annex IV

“ The EU declaration of conformity shall state that the requirements specified in this Regulation have been fulfilled in relation to the device that is covered. ... The EU declaration of conformity shall, as a minimum, contain the information set out in Annex IV and shall be translated into an official Union language or languages required by the Member State(s) in which the device is made available.” Annex IV requires: The above statement, details of the product(s) , details of the M and of the AR, if applicable, the basic UDI, risk class, applied common specifications, NB name, NB ID & listing of NB certificates • Is produced by the M – for example: “I hereby declare that the products listed comply with the applicable requirements of the MDR”

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

40