For those MedTech innovations sold or exported into Europe, the path to regulatory approval has grown much longer and more complex. A thorough and comprehensive set of standards, known as the Medical Device Regulation (MDR), has replaced a much less stringent set of guidelines, known as the Medical Device Directive (MDD). MDR is four times longer than MDD with a host of new classifications, and it sets high expectations for more demanding data collection and more rigorous post-market follow-up.
What does this mean? This means it is time for your regulatory strategies to progress into the future, and accomplishing that requires polished medical writing coupled with a comprehensive understanding of a changing industry. Failing to collect the right measurements ahead of time can leave gaps in your data down the road, and 90% of all reclassifications result in a costly regulatory review. Avoiding this fate is no easy task, especially since MDR has more exacting post-market clinical follow-up (PMCF) requirements and a longer, more nuanced list of classifications. In response, your medical writing must confront the MDR evolution and the three new realities of MedTech regulation.
1. A New Framework
There are 22 device classification rules under MDR, while there were only 18 under MDD.
Fundamentally, MDD and MDR are two very different types of laws. MDD is a simple outline of regulatory goals under which European countries may decide on their own how to achieve those goals through legislation. MDR is quite different, as it is a binding legislative act applied throughout Europe, and it ushers in a new framework for the defined risks and classification of each device.
Most notably, MDR begins by redefining the term “medical device” and offering new or modified classifications that are better suited for the 21st century. MDR is designed to raise safety standards across the board and encourage collaboration and transparency throughout a product’s life cycle. In doing so, it establishes a new framework for successful medical writing and the future of MedTech regulation.
- The word “safety” appears 290 times in MDR, as opposed to only 40 times in MDD
- A new class of “reusable instruments” has been established for future reprocessing efforts
- Software can now be considered a Class III device if it can irreversibly impact a patient’s health
- IVDs are now classified into four risk classes that will require notified body review for about 90% of the devices, up from the current 10%
2. New Data Standards
MDR requires data for all indications and locations, even if they only account for a small percentage of use cases.
MDR standards demand you “know your data.” The MDR requirements for collecting data extend throughout the life cycle of the product, so it is imperative to be aware of any gaps or inconsistencies in your current data sets. Notified bodies are becoming increasingly strict in their assessment of medical writing, which means you must (a) already have the data you need, (b) have access to a specialist who can help you get it, or (c) face a costly delay as you slowly backtrack to fill in the gaps.
- Equivalencies are especially difficult to achieve under MDR and often require the use of the same manufacturer
- Unique Device Identification (UDI) will be implemented to help track devices throughout the supply chain
- Manufacturers will need to report all incidents, injuries, and deaths into an EU portal that will centralize relevant data so that patients have access to more safety-related information
3. A New Proactive Approach
Data must be collected throughout the life cycle, and every device is now required to establish a PMS plan and PMCF protocols.
In an ideal world, you can confront these new standards before they become a problem for your studies. To do this, you must take an aggressive approach to your regulatory strategies and encourage a more proactive medical writing process with a focus on “knowing your data” and filling in the gaps from the very beginning. MDR requires deeper data at every level, which means that successful medical writing starts right now. To satisfy new data demands and shorten the path to market, your data collection must be comprehensive and ongoing, beginning with recruitment and exploration and continuing into complete post-market compliance.
- Proactive MDR guidance comes from Ph.D.-level specialists, expert medical writers, and innovators in data management
- Strategic documentation must now be kept continuously up to date, including the declaration of conformity, the summary of safety and clinical performance, and the clinical evaluation
- Manufacturers must collect feedback from users and screen relevant scientific literature for post-market success
Evolve Your Medical Writing
The path to approval is changing, and MedTech innovations need more guidance than ever to be successful in a regulatory world that is prioritizing caution and redundancy. Your medical writing is a crucial component of your MDR success, and producing precise medical writing now requires you to understand a changing framework and proactively collect the data you need to be successful from the very beginning.
As such, MDR presents a formidable challenge to all except the most knowledgeable specialists and most seasoned medical writers. Is your company in need of more detailed insight into MDR expectations? Read our white paper on The MDR Difference. What does it take to evolve your medical writing to meet a new reality? It Takes Avania.