Definition of a Medical Device: Explainer
MDR 2017/245 covers devices that previously fell under two separate European directives, the Medical Devices Directive (MDD 93/42/EEC) and the Active Implantable Medical Devices Directive (AIMDD 90/385/EEC). In this article, we look at the definition of a medical device and explain the types of products that might be classified as a device after May 2020. This article is part of our wider series looking at issues relating to the introduction of MDR.
Article 1 of MDR 2017/245 indicates the types of devices that are required to comply with these new regulations.
Definition of a Medical Device Under 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, treatment or alleviation of disease, disability or injury, where prevention of disability and injury is excluded
- Investigation replacement or modification of an anatomical, physiological or pathological process
- Providing data via in vitro examination of samples derived from a human body
- The MDR also identifies particular types of products that also qualify as medical devices:
- Products intended for cleaning, disinfection, and sterilization of medical devices
- Devices for the control and support of conception
- Products manufactured utilising nonviable human tissues or cells (and their derivatives) will now also be regulated under MDR.
Annex XVI of MDR 2017/245 lists groups of products that, even though they have no intended medical purpose, are required to meet MDR requirements.
These include devices used for aesthetic and cosmetic purposes, such as coloured contact lenses, dermal fillers, equipment used for liposuction, etc.
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 also covered under MDR 2017/245 (similar to the MDD 93/43/EEC).
However, as some products are now added to the definition of a medical device, it is now important to note that their accessories will also now be covered under the scope of the MDR.
Taking all this broadening of scope into account means that certain devices who were previously not covered under the MDD 93/42/EEC, now fall under the remit of MDR 2017/245.
In particular, there are now manufacturers, who previously were not subject to the requirements of MDD 93/42/EEC who are now subject to MDR 2017/245.
Risk Based Classification
- Classification of Medical Devices is based on risk as outlined in Annex VIII of MDR 2017/245.
- While the structure of the rules under MDR 2017/245 remain as per MDD93/42/EEC, there are now a number of additional Special Rules under MDR which mean there are now 22 rules in total.
- Devices classification range from Low Risk (Class 1) to High Risk (Class III).
- Active Implantable Device manufacturers should also note that MDR now covers Active Implantable devices and these are subject to the requirements of Class III devices.
- 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 device manufacturer that is now covered under the new MDR 2017/245 and are trying to understand what is required under MDR 207/245?
- Or are you a device manufacturer trying to determine whether your device falls under the scope of MDR 2017/245?
- Or even trying to determine how to 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.