The Medical Devices Introductory Course 2020

Key Guidance Documents

• MEDDEV 2.1/3 rev.3 – Drug Device Borderline [and Borderline Manual 1.22, 05/2019]

• MEDDEV 2.1/4 rev. 2 – Borderline and Classification issues

• MEDDEV 2.1/6 rev.1 – Qualification and Classification of stand alone software

• MEDDEV 2.4/1 rev.9 – Classification of medical devices

• MEDDEV 2.7/1 rev.4 – Clinical Evaluation

• MEDDEV 2.12/1 rev.8 – Medical Device Vigilance

• MEDDEV 2.12/2 rev. 2 – Post-Market Clinical Follow-Up

• MEDDEV 2.14/1 rev. 2 – Borderline and Classification issues (IVD)

The Organisation for Professionals in Regulatory Affairs

Drugs & Devices - A Comparison of Principles & Terminology

DRUGS - Discovery

DEVICES - Design

Fundamental differences and drivers: • Precautionary principle • Chemistry / biology based • Long term / high investment development cycle • Large, multinationals Terminology – the same but different: • Stability testing • Analytical testing • Specifications • Package insert / Patient Information Leaflet Requirements and regulatory elements: • Prescriptive / specific requirements • Current good manufacturing practice (cGMP) • Pharmaceutical development • Insert readability / usability testing • Product characterization and clinical studies • Technology transfer • Toxicology / pharmacokinetics / systemic effects • Clinical phases: 1, 2 and 3 • Pharmacovigilance • Clinical Phase 4 / Post approval studies

Fundamental differences and drivers: • Principle of Proportionality (risk-based) • Engineering / physics based • Fast-paced, rapid innovation cycle • Mostly small midsize enterprises Terminology – the same but different: • Ageing and lifetime studies • Bench testing / physical test methods • Technical drawings / design outputs • Instructions for use / User manual Requirements and regulatory elements: • General, wide-ranging requirements • Quality management systems (QMS / QSRs) • Design controls • Human factors • Design verification and validation • Design transfer • Biocompatibility / contact / local effects • Clinical feasibility / pivotal studies • Medical device vigilance and reporting (MDRs) • Post-market clinical follow-up (PMCF)

The Organisation for Professionals in Regulatory Affairs