What is a Medical Device under MDR 2017/245?
We first published this article in 2020. This revised article considers the definition of a medical device and explore the types of products that may fall in under the classification of a medical device post May 2021.
MDR 2017/245 covers devices that were previously under the scope of two separate European directives:
- Medical Devices Directive (MDD 93/42/EEC)
- Active Implantable Medical Devices Directive (AIMDD 90/385/EEC).
MDR 2017/245 – Article 1 explicitly references the types of devices that are required to comply with the MDR.
MDR 2017/245 – Article 2
Article 2 of the MDR 2017/245 defines the term “medical device” as any “instrument, apparatus, appliance, software, implant, reagent, material or another article” intended to be used for any of the following medical purposes:
- diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
- investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
- providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
Some examples of other products identified as medical devices include but is not limited to:
- devices for the control or support of conception
- products intended for the cleaning, disinfection, or sterilisation of devices
Accessories (which are products that are intended to enable a device to be used in accordance with its intended purpose or to assist the medical functionality of the medical device) are covered under the scope of MDR 2017/245 (similar to the MDD 93/43/EEC).
With the expansion of the scope of MDR 2017/245 in terms of devices, it is important to note that certain devices which were not previously covered under MDD 93/42/EEC are now included under the remit of MDR 2017/245. In addition to this, many manufacturers who previously were not subject to the requirements of MDD 93/42/EEC now find themselves working towards compliance to MDR 2017/245.
MDR 2017/245 – Article 51 – Classification of Devices
- Classification of Medical Devices takes into account the intended purpose of the device and the associated inherent risk.
- New classification rules under the scope of MDR.
- As a manufacturer is it important to consult the regulations directly to determine whether your medical device is covered under the new MDR 2017/245.
Some Questions to Consider
- Are you a medical device manufacturer that is now covered under the new MDR 2017/245 and are trying to understand what is required under MDR 207/245?
- Are you a medical device manufacturer trying to determine whether your device falls under the scope of MDR 2017/245?
- Can you classify your medical device under MDR 2017/245?
- Are you aware of your responsibilities under EU MDR? Do you have the resources and systems in place to fulfil your obligations under the new Regulations?
We Can Help
Determining if your product classifies as a device and determining its classification is a complex issue. We can help you. Our medical devices team is staffed by MDR experts who have extensive experience in the devices sector. Complete the form below or call us on 00353 52 61 76 706.