Module 18 2021

05/02/2021

Breakdown of Types of Device- Drug Products

Other 15%

Vascular 24%

Woundcare 21%

Orthopaedic 15%

Active Implantable 15%

Latex 10%

The Organisation for Professionals in Regulatory Affairs

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Conformity Assessment for Device-Drug Products

• Class III Medical Device • meet and satisfy the essential requirements, as evidenced by the manufacturers documentation as detailed in Annex I of MDR 2017/745 • be subject to the reporting requirements under the medical device vigilance system; • bear the CE mark with the exception of custom-made devices and devices intended for clinical investigation

The Organisation for Professionals in Regulatory Affairs

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