Is the growing regulatory complexity making you uncertain which direction to go?
Need some words of wisdom?
Here are 7 quotes from 2023 to help you navigate through the regulatory fog.
1.A successful regulatory strategy begins with the end in mind
(Source: Informa Connect – Medtech Digital Week, Navigating Regulatory Affairs and Ensuring Compliance in a Medtech Scale Up)
A well-thought-out regulatory strategy plays a key role in getting the device to the market and keeping it there.
When you start by defining the device’s intended purpose and understanding user needs and regulatory requirements per target market, you can develop the device while taking care of compliance and business needs.
2.There will be circles and curves
(Greenlight Guru – State of Medical Device True Quality Summit Series, Leveraging Modern Software Technologies MedTech’s Best Kept Secret)
This quote for me is about how the strict regulations and compliance activities slow down many things in the medtech industry. This includes the go-to-market speed of the products.
You’ll save yourself a lot of time and money if you’re able to adapt to changes and are prepared to get to know the regulations, as well as have buffer in schedules.
3.Risk management file is a tool of communication. Try to keep it efficient.
(Naveen Agarwal – Risk Management File Documentation Made Easy)
This quote describes a useful mindset to have when creating and updating the risk management file documentation.
Risk management file documentation is essentially manufacturer’s communication instrument both internally and externally. It helps the team do their job in better collaboration. Also, it allows the notified body and competent authorities to understand the device, how the company is conducting risk management and to make decisions of the conformity of the device based on the information received.
4.Don’t pick an algorithm. Pick a strategy.
(Karolinska Universitetssjukhuset – Implementing AI in healthcare learnings and reflections)
I consider the quote relevant for two reasons.
While technology and technological innovations are important, the objective and intent of what you want to achieve shouldn’t take a backseat. Treat the patient and not the data.
5.Medical evidence is the currency in market access
(Business Finland – German market access and reimbursement)
This quote highlights that the clinical proof of device benefits, and creating a positive healthcare outcome, are essential in getting approval for market entry. They’re also vital to make the customers interested in buying and using the device in the long term.
The quote emphasises the value of real-world evidence, as well as proper risk management and clinical evaluation.
6.Make a story
(BSI – Clinical Masterclass Series Part 2, Preparing a Clinical Evaluation Plan)
The point with this quote is that if a medical device manufacturer simply dumps clinical data on the external reviewer (mainly the notified body) and sees what sticks, they won’t get far.
Manufacturers have a better chance of getting clinical evaluations approved in reasonable time if they present their devices’ clinical safety and performance through a narrative of connected events.
(Practically everyone: the notified bodies, the MDCG, the competent authorities and many others)
This quote was the main MDR message to medical device manufacturers in 2023.
The staggered and conditional extension of the transition period until 2027/2028, which was introduced in March 2023, was widely misunderstood among medical device manufacturers. Many took the extension as a permission to take the foot off the gas.
However, in reality the extension was meant for notified bodies. They would have more time to process MDR conformity assessment applications before device certificates expire. This would help to avoid a shortage of critical devices on the market.
Therefore, manufacturers should continue getting their MDR conformity assessment submissions ready and submit them without any delay.
Do you have any engaging or insightful quotes from 2023 in mind? Please share them in the comments below.
And if you have any questions or concerns about the MDR, you’re welcome to send me a message.
I’m always happy to listen to what’s on your mind and help you take the next step.