Module 18 2021

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

43

43

Thank you

Clarification?

Questions?

44

44

22