The Medical Device Regulation (EU) 2020/561, amending Regulation (EU) 2017/745 defines an active device as any device, the 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 […]. This definition is mirroring the same wording of active devices appears in the Medical Devices Directive (93/42/EEC).
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.
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 has introduced a new specific rule to software called Rule 11, which categorizes software as
- software intended to provide information […],
- software intended to monitor physiological process […] and
- all other software.
Upon this rule software can be classified from class I to class III.
Based on the Regulation (EU) 2017/745 and the Directive 93/42/EEC, Software is deemed to be an active device.
Harmonized standards and Active devices
Article 8 of the Regulation (EU) 2017/745 and Article 5(1) of the Directive 93/42/EEC support the use of harmonized standards (published in the Official Journal of the European Union) to demonstrate the conformity with the requirements of respective MDR and MDD covered by those standards.
Majority of Active medical devices are Electromedical devices (refers to as Medical Electrical Equipment by standard). Electromedical devices can be used for:
- Patient Diagnostic such as Medical imaging systems or monitoring devices, and
- Patient Treatment such as surgical lasers or high intensity focused ultrasound (HIFU)
A widely recognized standard which address Basic safety and Essential performance requirements of medical electrical equipment (Active devices) is the family of IEC/EN 60601 Standards:
- IEC/EN 60601-1 (general standard)
- EC/EN 60601-2-xx: Particular standards which are product specific. They may modify, add, or delete requirements of the general standard.
- IEC/EN 60601-1-xx: Collateral standards apply to a specific characteristic of all electromedical equipment’s not fully addressed in main standard or to a subgroup of electromedical equipment.
Other standards called by the IEC/EN 60601-1 standard such as IEC/EN 62304 (software application) and IEC/EN 62366-1 (Usability), specific standards applicable on specific components as batteries […] are also applicable.
Our teams of experts, dedicated to the health care and medical devices industry, and our proven practices make GMED among the leading companies at an international level.
GMED is a well-known notified body thanks to its experience and state of the art knowledge of all types of medical devices including high-risk and innovative devices.