If you have a device, or multiple devices available in different countries, ensuring that your compliance procedures and certifications are up to scratch and compliant everywhere calls for a team with a broad breadth of experience and can require a significant work of harmonization.
Not only will your business need to have experts that know all about the EU MDR, UKCA marking and how to work with the FDA, to name just a few, but they will need to also keep on top of not infrequent changes affecting the international markets devices are being marketed in.
The UK’s exit from the EU and development of its own regulatory framework, the constant changes surrounding timelines for the EUMDR and IVDR, combined with the growing onus of PMCF requirements for example, are putting unprecedented pressure on many businesses. As more than eight in ten companies say the time it takes to secure permits is a barrier to investing in Europe, and 53% of companies call it “a serious problem”, it is not surprising to hear many medical device manufacturers are opting to pull out of Europe and are increasingly looking at other international markets like the Middle East and Singapore.
But expanding into new markets will require new skills and regulatory knowledge. As a result, many in-house regulatory departments are starting to feel rightly overwhelmed.
Harmonizing the requirements from the different regulatory frameworks, so that measures required for in one market can also help ensure compliance on another market, can help streamline compliance processes and ease the burden on regulatory teams.
Leeanne Baker, Managing Director and Senior QA/RA Consultant at IMed Consultancy analyses struggles faced by businesses trying to stay up to date with regulatory change internationally and explains how overlap between regulatory requirements can help harmonize internal processes improving efficiency as well as compliance.