Essentials of European Medical Device Regulatory Affairs - June 2020

Concept of Time

• Application quick, but in situ for longer e.g. cream

• Continuous use: uninterrupted actual use of the device for the intended purpose.

• However where usage of a device is discontinued in order for the device to be replaced immediately by the same or an identical device this shall be considered an extension of the continuous use of the device

Ref: MDR Annex VIII Chapter II 3.6

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Active Medical Device

• Any medical device operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy. • Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be deemed to be active devices.

• Hearing aids, TENs machines, light boxes to treat SAD

• Stand alone software is considered to be an active medical device. Ref: MDR Article 2 An active non implantable regulated by this MDD now MDR. Active implantable was regulated by Directive 90/385/EEC but now MDR . MEDDEV 2.1/6 Guidance on software (what is and what is not a medical device)

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How to Apply the Rules

• Manufacturer decides on the basis of the decision rules in the MDD(Annex IX) MDR Annex VIII and the intended purpose of the device

• Decision criteria: time, invasiveness, powered or not (active/non- active), presence of drugs

• All rules must be considered • For multipurpose devices the highest class applies • For devices used together consider classification separately • Accessories need to be classified in their own right

TheOrganisation for Professionals in Regulatory Affairs

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