The Medical Devices Introductory Course 2020

• Extra requirements • Applies to devices incorporating a medicinal product (5.2), tissue containing devices (5.3) and devices which are absorbed/dispersed (5.4). • Before issuing an EU Technical Documentation Assessment Certificate the NB shall … seek a scientific opinion from a Competent Authority or, in the case of 5.2 and 5.4 the EMA . Annex IX.5.2, 5.3 and 5.4: Further scrutiny for high risk devices

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

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Class III Device (MDR Article 52.3) including those with medicinal substances, human tissues or animal tissues

Annex IX Ch II Technical Documentation Every device

Annex X Type Examination inc Technical Documentation

Annex XI – Part A Production Quality Assurance

Annex IX Ch I & Ch III QMS / Admin

Annex XI – Part B Product Verification

Consultation – 2001/83/EC, 2004/23/EC, 722/2012/EU (Section 6, Ann VIII)

Declaration of Conformity (Annex IV) & CE Marking (Annex V)

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The Organisation for Professionals in Regulatory Affairs