In many ways, the COVID-19 pandemic brought the healthcare industry to a halt. An all-hands-on-deck strategy was needed to treat those critically affected by the virus and protect others from infection. This also meant the necessary delay of countless elective procedures. As patients waited to reschedule appointments, medical device manufacturers slowed production to match waning demand. The rippling effects of the pandemic also delayed implementation of new European Medical Device Regulation (EU/MDR)
Originally passed in 2017, the EU/MDR did not go into effect until May 2021. After years of speculation, engineering teams are now experiencing the effects of these new regulations.
As with most legislation, there’s a lot to sort through when it comes to the new EU Medical Device Regulation. Since its passage, companies have been pouring over the 123 articles, 17 annexes and over 175 pages that spell out the exact requirements being introduced or revised by this new framework. Reports indicate that MDR is applicable to, “a manufacturer, authorized representative, importer or distributor of medical devices in the EU, or a regulatory affairs or quality management professional involved with medical devices.” Equally sweeping in scope are the devices covered by the legislation.
Here’s how the new rules define a medical device which may be affected by the new compliance requirements:
“Any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
- Diagnosing, preventing, monitoring, and treating diseases
- Diagnosing, preventing, monitoring, and treating injuries or disabilities
- Investigating, replacing, or modifying part of a person’s anatomy, physiology, or pathological process or state
- Providing in vitro examinations of human specimens like organ, blood, and tissue samples
- Controlling or supporting contraception
- Cleaning, disinfecting, or sterilizing aforementioned devices”
Beyond identifying who must comply with the new rules, this legislation includes a variety of documentation requirements, including:
- Lab Changes
- Instructions for Use
- Certificates Issues by a Notified Body
- Declaration of Conformity
- Scope and Classifications
- Certificates of Free Sale
Additionally, manufacturers must now also clear a higher bar of requirements in order to operate in the European Union. In particular, organizations will need to:
- Prove the ability to cover financial damages caused by effective devices
- Name a person responsible for compliance
- And manufacturers outside of the EU/European Economic Area (EEA) must maintain direct contact with a representative within the EU/EEA.
In short, manufacturers must be ready to actively swiftly in the event of a recall.
According to Mobi Health News, this expansive change to regulation rules can have a major impact on people using the more than 500,000 types of medical devices on the market today. As the demand for devices increases following lengthy COVID-related delays, manufacturers must be ready to meet the moment. Beyond implementing new quality management and automation systems, companies are being forced to ramp up their hiring processes quickly. Organizations are scrambling to hire skilled personnel in the areas of quality, regulatory, production/manufacturing and engineering.
New and exciting medical devices can make meaningful differences in the lives of patients. However, before they can hit the market, they must hold up to increasing scrutiny. If not, the device will rightfully not be able to be sold or utilized in a clinic or hospital. It’s time for device manufacturers to ensure their teams are built to withstand this changing market.
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