Definition of a Medical Device Under Article 2Article 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.
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?