The medtech regulatory environment in Europe has entered a new era. A Europe-wide medical device regulation has come into effect, presenting both challenges and opportunities for stakeholders in the sector.
With only one month until the compliance deadline, many medical device companies still have much to prepare in order to meet the requirements.
Investments in new processes and systems must satisfy the needs of the authorities and ensure patient safety and public confidence. Getting it right is likely to be expensive. but regulatory compliance shouldn’t be viewed purely as a cost center.
The latest regulations for human and veterinary medicinal products, as well as medical devices, include the mandate to set up databases with detailed information about available products. These databases must be realized and implemented in the near future, and require a concerted effort now if tangible real-world benefits are to follow.
A discussion of the changing medtech markets and how companies can remain cognizant of potentially disruptive changes in their business and industry for future success in their product portfolios, services and relationships.
The outlook for 2020 and beyond is positive, but medical device companies must continue to evolve their technologies and partnerships to keep the attention of investors.
The agency anticipates the program will result in a two-thirds reduction of the amount of device malfunction reports submitted by manufacturers.
After one year into the transition period, it is clear that manufacturers are not where they need to be in meeting the compliance deadline.
Here’s a hint: Compliance with new regulation in Europe is a high priority.
How in touch are you with current MDR guidelines?