The EU MDR (Medical Device Regulation) was originally going to enter into force in May 2020. Just 2 months prior, the European Commission (EC) proposed to delay the compliance deadline for a year. Parliament unanimously voted in favor on April 17, 2020 and member states adopted the proposal 1 week later.
Medtechs welcomed the announcement, having been rather busy dealing with the pandemic crisis. Even with the delay, the task is daunting since complying with MDR presents significant challenges due to important requirement changes and additions.
While the delay comes as a relief for medical device manufacturers that are currently under heavy pressure, organizations should by no means become complacent. There is no reason to postpone efforts and take all necessary steps to ensure devices will be in conformity by May next year.
The Purpose of the EU MDR Delay
Providing businesses with 12 extra months to get ready is only a side effect of the delay.
The EC realized COVID-19 has put a great strain on healthcare providers and facilities, as well as on distributors facing increased urgent demand that forced them to redirect resources. A shortage of currently certified devices resulting from pulling products from the market because they fail to comply with MDR requirements would pose a greater risk to people’s health.
As per the EC’s press release:
“Any potential market disruptions regarding the availability of safe and essential medical devices must and will be avoided.”
To gain some perspective on the impact of the decision, Europe has reported over 2.5 million cases, with more than 850,000 still active (data as of July 7, 2020). Critical care beds’ availability greatly differs between member states. Some hospitals have reached max capacity in their ICUs at the surge of the pandemic. If you take into account that COVID-19 is layered on top of regular needs for devices to treat other illnesses and ensure emergency care of non-pandemic nature, you’ll see why maintaining the original compliance date of May 2020 would have presented too great a risk to public health.
EU MDR Overview
The new MDR is a nearly complete overhaul of its predecessor MDD, extensively widening the scope of application and decidedly geared toward more transparency on patients’ safety throughout the device lifecycle.
Broader Definition and Classification Changes
If some of your products were not falling within the scope of MDD, this may change. The list of concerned products has been revised, some added (such as cosmetic fillers and equipment cleaning products.), and some promoted to a higher-risk class which means more stringent requirements.
Regardless, you have to perform a thorough assessment of your portfolio and the impact on your supply chain partners.
Device Traceability
Each medical device will be assigned a UPI (Unique Product Identifier) and a UDI (Unique Device Identifier) for which core data will be accessible to the public via EUDAMED.
EUDAMED
EUDAMED is the European database that collects, stores, and organizes data regarding manufacturers and their products, regulatory bodies, clinical trials, post-market surveillance reports, and incidents.
The requirement to report to EUDAMED comes with the requirement to update your Quality Management Systems so you can store documentation, link to post-market surveillance processes and conduct post-marketing vigilance.
Substances of Very High Concerns
Annex I of the MDR gives particular attention to specific devices and the SVHCs they may contain. Such products include those that come into contact with the body, (re)administer medicines, fluids or gases to or from the body, transport or store medicines, fluids or substances.
Know that being in compliance with EU REACH regulation may not be enough, as MDR’s substances list of concern is more extensive. You need to reach out to your suppliers and collect their disclosures of MDR-relevant substances present in the products.
COVID Era Challenges Pertaining to Compliance Programs
Social distancing is the new normal for now, travel is restricted, safety first is a new daily mantra. While working from home and taking care of business via conference calls may not disrupt certain activities, working toward medical device compliance can be more difficult, especially where obtaining certification or re-certification traditionally involving field audits.
The Medical Device Coordination Group (MDCG) has issued Guidance on Temporary Extraordinary Measures Related to Medical Device Notified Body Audits During COVID-19 Quarantine Orders and Travel Restrictions.
To some extent, allowing remote audits cuts some slack for notified bodies and manufacturers but does not compromise on data and information integrity and security.
The same caveats apply to medical device companies who usually perform on-site audits deemed critical to ascertain adherence to medical device various regulations. Moving to the digital side of conducting business requires adequate technology and tools, especially in terms of cybersecurity and data protection.
What the EU MDR Delay Means for You
This delay is only a short breath of fresh air. In 10 months, the new European Medical Devices Regulation will come into effect. If you have slowed your pace in your compliance action plan, now would be the time to pick it up.
Take the time the EU gives you to study your options, available resources, and the progress accomplished so far.
Bearing in mind the rest of the year is still cast in a hazy fog of economic uncertainty and the looming threat of a second wave of coronavirus, practice an exercise of business introspection:
- Where are your resources most needed now? In 3 months, in 6 months?
- Do you have enough in-house capabilities to cover the entire array of what MDR implies?
- Are you willing to take your eyes off the COVID recovery ball to enter the race to compliance?
- Are you confident your suppliers (themselves dealing with the crisis) will be responsive and actively engaged?
- Do you have the technology and operational bandwidth to tackle all your compliance priorities, both domestically and globally?
Considering the current environment and the difficulty to forecast the next 10 months, solutions may seem few and far between. If we assume there will not be a second delay (as we should), putting MDR on the back burner will only result in more stress and more strain on manpower and budgets.
Third-Party EU MDR Compliance Solution
Source Intelligence is ready to jump on board and get you up to par within the timeframe. Our AI-powered platform dedicated to MDR compliance is specifically designed to relieve you of the time-consuming tasks of collecting and compiling supplier data, validating information, and helping you identify which of your products are affected.
The EU MDR delay highlights the commitment to support businesses and the healthcare systems to overcome the crisis. We suggest you do not delay getting the high-performance tools that will help you benefit from this extra-time.
Request a demo of our MDR solution to see how we can take the EU MDR burden off your shoulders.
