Essentials of European Medical Device Regulatory Affairs

Transitional provisions for certificates issued under the old Directives Certificates issued prior to the entry into force of MDR remain valid for the period indicated on the certificate: • Except certificates under Annex 4, Directive 90/385/EEC or Annex IV, Directive 93/42/EEC, which expire at the latest 2 years after the Date of Application (DoA) – EC Type verification Certificates issued during the transition period remain valid for the period indicated (maximum 5 years), but expire at the latest 4 years after the DoA: • Certificate MDD Jan 2020 – expiry May 2024 • Certificate MDD May 2019 – expiry May 2024 Devices legally placed on the market under the Directives prior to the DoA may be made available up to 4 years after that date. • Certificate MDD Jan 2020 - if on market can be sold to May 2024 • Certificate MDD May 2019 - if on market can be sold to May 2024

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MDD – 93/42/EEC

• 35 Recitals (background, justification, scope) • 23 Articles (describes general principles, definitions) • 12 Annexes (specific requirements) • I: essential requirements • II to VII: procedures to demonstrate conformity 

• VIII: devices for special purposes • IX: definitions , classification rules • X: clinical evaluations • XI: notified bodies • XII: CE mark 

• Total pages: 60.

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