With only one month until the compliance deadline, many medical device companies still have much to prepare in order to meet the requirements.
Anyone can read the regulation. The challenge is in how to apply it to your company’s structure and product line.
Although medical device manufacturers have more time to prepare due to the delayed EU MDR deadline, this shouldn’t distract from the extensive documentation they must compile in the meantime to prove their devices are compliant.
Timely compliance will ensure that your products will not be considered misbranded.
Sources of reliable data to continuously support claims of compliance by manufacturers will be in high demand in the future.
For too long this industry has lagged the pharma sector in terms of using data analytics to predict market trends. It’s time to change that.
By simplifying labeling compliance, companies can focus on better serving current and new markets.
Upgrading your enterprise labeling system could play a key role in ensuring compliance.
U.S. medtech manufacturers must also prepare for the UDI requirements under EU MDR.
With just over a year remaining before the EU MDR and IVDR regulations go into effect, many in the medical device industry are shifting their compliance efforts into high gear—a somewhat tedious task given the industry is still waiting on functional specifications for Eudamed.