The new MDR, or Medical Devices Regulation, which will come in to effect by 2020 is set to have an affect upon many different companies and industries in the EU as some products which do not have an intended medical purpose will need to be compliant with the regulations. This breakdown will clearly show the differences between the old MDR regulations and those which will come into full effect by May 2020.
What Is A Medical Device?
First and foremost, the definition of a “Medical Device” is key as new regulations will cover devices which were not always intended to fill this role. A medical device is “any instrument, apparatus, appliance, software, implant, reagent, material, or other article to be used, alone or in combination, for human beings” in a medical setting. This could be:
● Dental equipment
● Surgical implements
● Hospital beds
● Treatment chairsdical treatment.
This definition, and indeed these regulations, cover “In Vitro” medical devices too. These are devices which are intended to aid the examination of specimens, including blood, bodily fluids, and tissue, derived from the human body. These can include:
● Pregnancy tests
● Glucose monitors
● Thrush/Bacterial vaginosis tests
There are also “borderline” examples and products like medicated surgical dressings and head lice products which have yet to be fully classified.
What Has Changed?
Several updates and changes have been made to regulations covering both Medical Devices and Invitro Devices. Changes to quality and risk management procedures, changes to device classification, changes to the notified bodies involved, and post-market surveillance and vigilance have been laid out. The goal, of course, is to ensure that medical devices and in vitro medical devices which make it to the public are consistently high quality and fit for their intended purposes!
Quality, Risk, And Classification
Companies which produce devices or products covered by these new regulations will now be required to create a documented risk management plan. This plan should identify potential risks associated with the use of the device, and evaluate the information gained from the production phase to do so. As a part of this, manufacturers will also be required to create a post-market surveillance plan.
The classification of medical devices will still be based upon level of risk with devices being classed as class I, II, or III (or A, B, or C for in vitro medical devices). Certain devices, however, will be changing classification. For example, certain devices which encounter the spinal cord will now be up-classified to class III rather than class III; anything above class I or A will require approval from the official “Notified Bodies” (including class I sterile and class I metrology/measuring), while Class I and A devices can be subject to self-assessment.
These changes will be subject to conformity assessment and random auditing.
Notified Bodies, Pre-Market Checks, And Traceability
Manufacturers will not only be affected by changes which regulate the production process, but by changes which affect the way products are assessed and analysed. When the new MDR regulations come into force the notified bodies which assess class II and III (and B and C) products will have strengthened designation criteria to follow, will be able to conduct joint audits, and will not be required to notify manufacturers of upcoming audits.
This is designed to minimise grey areas and borderline products, and to increase consistency and quality across the board.
Manufacturers will also be required to carry out pre-market checks which have an increased level of scrutiny for high risk (class III or C) devices as well as having authorised representatives and a responsible person as a point of contact for notified bodies and regulators. Furthermore, the transparency and traceability of devices is to be increased through a central registration system, unique device identification numbers (UDI), and implant cards.
In a concentrated attempt to increase transparency and accessibility, MDR will also make information available to the public through a new database: “the European Database on Medical Devices” or EUDAMED.
This database will include information of the devices themselves, on market surveillance, clinical investigation, performance, and safety. This database will also include the UDI for each product so that information can be easily found under a unique signifier.
So, in short, while not every aspect of the new MDR regulations will directly affect the day to day process of production all manufacturers of medical devices and in vitro medical devices will be required to be compliant with the following changes before May 2020. The goal is to increase patient safety, product quality, and public access to information on the medical devices which are at every stage in medical treatment.