The changes are significant. Here’s what you must know.
The EU Medical Device Regulation sets the stage for an arena where transparency, quality, and patient safety are paramount. Manufacturers must prepare and build compliance into their product development strategy to ensure a successful transition to this new regulatory environment.
Medical devices play an increasingly critical role in the health and quality of life of millions of people worldwide. To reflect the substantial technological and scientific advances made by the medical device sector and to respond to the need for regulations that would significantly tighten the controls around medical devices, the European Commission published the EU Medical Devices Regulation (MDR) on May 5, 2017. These new, more rigorous regulations seek to set the standard for medical device regulation globally and impact the entire product development cycle, from concept to clinical trial conduct and post-marketing surveillance.
Key regulation changes under the EU MDR
The MDR replaces Directive 93/42/EEC regarding medical devices (MDD) and Directive 90/385/EEC regarding active implantable medical devices. The MDR will enter into full force in May 2020 and all CE Mark certifications issued before the implementation of this new regulation will automatically expire in May 2021.
With the looming deadline for compliance with the MDR, device manufacturers face a host of questions about how to prepare their products for compliance. Any manufacturer who intends to market their medical device in the EU member states – including manufacturers who already have devices on the market – must be compliant with the EU MDR. There are no grandfathering provisions with the regulation, and all currently approved devices must be re-certified in accordance with the new requirements.
Expanded definition of medical devices
Under the EU MDR, the definition of a medical device is any instrument, apparatus, appliance, software, implant, reagent, material, or other 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 data via in vitro examination of samples derived from a human body
- Cleaning, disinfection, or sterilization of medical devices and devices for control or support of conception
The inclusion of devices that do not have medical-intended purposes and devices designed for the purpose of prediction of a disease or health condition represents a notable expansion of the previous definition of medical devices.