The Medical Devices Introductory Course 2020

MDD: Manufacturer must have available technical documentation describing each product/product family - typically containing: – Device description and classification – Declaration of Conformity – Essential / GSP Requirements Checklist – Risk Management File (including Risk Assessment) – Location and allocation of responsibilities (for design and manufacture) – Design specifications, verification/validation records and test results – Pre-Clinical and Clinical data (Biological and Clinical Evaluation Reports) – Labelling and instructions for use – Data on any animal derived materials, medicinal substances For Class III devices a more comprehensive type of technical file including information on product design. These are submitted to the Notified Bodies for assessment and approval before the CE mark is applied. (3-15 months depending on whether NB has to consult other agencies). A Design Examination Certificate is issued by the NB. CE Mark Technical Documentation MDR: Format of Technical Documentation and associated requirements defined in Annex II and III Similar to STED Increased documentation review for certain Class IIb (implants, rug delivery devices and b orbed substances) More devices sampled by NB for IIb versus IIa

Introduction to Medical Devices Regulation in Europe

The Organisation for Professionals in Regulatory Affairs

Standards & Common Specifications per MDR

• Harmonised Standards are mandated by the EU (in the Official Journal)

• Compliance with standards is not mandatory, but is a useful means of complying with the ‘Essential Requirements’ / GSPRs

• Justification may be required where harmonised standards are not met • Compliance required for Common Specifications (MDR)

• Developed by various organisations (international or national), e.g.: ISO, IEC, CEN, CENELEC

• Standards and Norms may be ‘horizontal’ (generic) or ‘vertical’ (product specific)

Introduction to Medical Devices Regulation in Europe

The Organisation for Professionals in Regulatory Affairs