Module 18 - Drug Device Combinations and Other Technologies

Guidance Documents

Classification:

• MEDDEV 2.4/1 - classification • MEDDEV 2.1/1 - definitions

• MEDDEV 2.1/5 – measuring function • MEDDEV 2.1/2 - Active Implantables

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Guidance Documents

Borderlines with medicines: • MEDDEV 2.1/3 – demarcation & consultation

IVD Borderlines: • MEDDEV 2.14/1 – Borderline issues • MEDDEV 2.14/2 – research use only products

Other: • MEDDEV 2.1/4 – Interface with PPE and electromagnetic equipment

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