Paul Dunleavy, Senior Vice President of Engineering
Transition into Medical Devices Regulation (MDR)
In May 2017, the European Commission (EC) announced two new medical device regulations, Medical Devices Regulation (2017/745/EU) (MDR) and In vitro Diagnostic Medical Devices Regulation (2017/746/EU) (IVDR). MDR has a four year transition period and has become applicable since May 26, 2021. The IVDR date of application will be in May 2022. The new regulations will replace the current Medical Devices Directive (93/745/EU) (MDD) creating a more robust, transparent, and sustainable regulatory framework for medical devices and will help ensure better protection of public health and patient safety.
Differences Between MDR and MDD
The MDR and MDD share the same basic regulatory requirements. According to the EC, no existing requirements have been removed but new requirements have been added to the MDR. Some of the additions include:
- More emphasis on life-cycle approach to safety
- Increased control and monitoring by national competent authorities and the EC
- Reclassification of devices, wider scope of devices
- Coverage of internet sales of medical devices
- Introduction of clinical evaluation consultation procedure
- New Unique Device Identification system with enhanced traceability and post-market surveillance
- Increased transparency with clinical studies and devices
What Devices Fall Under the Scope of MDR?
The first step is to determine if your product is considered a medical device by the EC. Devices that may not have been considered a medical device under the MDD may now be in the MDR. The MDR defines a medical device in Article 2 as “any instrument, apparatus, appliance, software, implant, reagent, material or other article” intended by the manufacturer to be used for one or more of the following specific 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
The following products shall also be deemed to be medical devices:
- Devices for the control or support of conception
- Products specifically intended for the cleaning, disinfection or sterilization of devices
Will MDR Regulations Impact Your Product?
If your product meets any of the criteria above, your product is considered a medical device and falls within the new MDR regulations. The next step is to draw up an action plan and understand what you need to do to maintain compliance to MDR (2017/745/EU). You can visit the European Commission website for a step-by-step guide and more useful information.
Devising an action plan is also the best time to connect with an organization that is experienced in medical device manufacturing and can ensure compliance while bringing your product to market before your competition. The Cogmedix DFcx™ Engineering Services group is committed to supporting our customers at any stage in a device’s lifecycle. Let us become an extension of your team and work collaboratively and compliantly to deliver your device to market together!
Want to work with medical manufacturing experts who can help you ensure compliance? Contact Cogmedix today.