Essentials of European Medical Device Regulatory Affairs

Classification of medical devices Significant changes in the MDR

Substance-based MDR Annex VIII (Rule 21)

• In class III if they, or their products of metabolism, are systemically absorbed by the human body in order to achieve the intended purpose • In class III if they achieve their intended purpose in the stomach or lower gastrointestinal tract and they, or their products of metabolism, are systemically absorbed by the human body • In class IIb in all other cases, except if they are applied on skin, in which case they are in class IIa, or • If they are applied in the nasal or oral cavity as far as the pharynx, and achieve their intended purpose on those cavities, in which case they are in class IIa

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Classification of medical devices Significant changes in the MDR Active Therapeutic Device with a diagnostic function MDR Annex VIII (Rule 22) • Active therapeutic devices with an integrated or incorporated diagnostic function, which significantly determines the patient management by the device are in class III, such as closed loop systems or automated external defibrillators

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