Electromedical Devices
(EMD)
The Medical Device Regulation (EU) 2020/561, which amends Regulation (EU) 2017/745 defines an active device as any device whose operation 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 […]. This definition mirrors the wording used for active devices in the Medical Devices Directive (93/42/EEC).
Classification Rules for Active Medical Devices
The new Regulation (EU) 2017/745 addresses the classification rules of medical devices in Annex VIII. Rules specific to active medical devices are covered under Rules 9 to 13, and some of special rules including rule 17 and rule 22.
Additional Requirement for Certain Class IIb Devices
Another new requirement for active devices under the new regulation is related to class IIb active devices intended to administer and/or remove a medicinal product. These devices must be subject to requirements for clinical evaluation consultation, same as required by section 54 for class III implantable devices.
Software and active devices
Regulation (EU) 2017/745 introduced a specific rule for software: Rule 11. Under this rule, software is categorized as:
- software intended to provide information […]
- software intended to monitor physiological processes […]
- all other software
As a result, software can be classified from Class I to Class III.
In addition, based on Regulation (EU) 2017/745 and Directive 93/42/EEC, software is considered an active device.
Harmonized standards and Active devices
Harmonized Standards and Regulatory Conformity
Article 8 of Regulation (EU) 2017/745 and Article 5(1) of Directive 93/42/EEC support the use of harmonized standards, as published in the Official Journal of the European Union, to demonstrate conformity with the requirements of the respective MDR and MDD covered by those standards.
Electromedical Devices as Active Medical Devices
The majority of active medical devices are electromedical devices, which are referred to as medical electrical equipment in the standard. These devices can be used for two main purposes:
- Patient diagnosis, such as medical imaging systems or monitoring devices
- Patient treatment, such as surgical lasers or high intensity focused ultrasound (HIFU)
Relevant IEC/EN 60601 Standards
A widely recognized standard family that addresses the basic safety and essential performance requirements of medical electrical equipment, or active devices, is the IEC/EN 60601 series.
This family includes:
- IEC/EN 60601-1: the general standard
- IEC/EN 60601-2-xx: particular standards that are product-specific. These standards may modify, add to, or delete requirements from the general standard.
- IEC/EN 60601-1-xx: collateral standards that apply to a specific characteristic of all electromedical equipment not fully addressed in the main standard, or to a subgroup of electromedical equipment
Additional Applicable Standards
In addition, other standards referenced by IEC/EN 60601-1 may also apply. These include, for example:
- IEC/EN 62304 for software application
- IEC/EN 62366-1 for usability
- Specific standards applicable to certain components, such as batteries
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