- Medical Devices Directive (MDD 93/42/EEC)
- Active Implantable Medical Devices Directive (AIMDD 90/385/EEC).
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
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?