Transforming challenges into opportunities
Despite the significant amount of resources that are required to reach and maintain compliance, there are many opportunities in the IVDR. To start, when you consider that authorities and companies around the globe are now working together to deliver what the patient needs according to a single rule book, you can begin to see the real power of IVDR. In the past, under IVDD, countries were able to interpret the rules for their local markets leading to discrepancies and confusions. This also made selling into different markets challenging. Now with IDVR, everyone is subject to the exact same rules when placing IVDs on the EU market allowing greater consistency and higher quality.
It is also important to note that we are all in this together. Regulators, notified bodies, big and small companies alike are all facing the same challenge. This is a great opportunity to reach out and forge new relationships and partnerships that can benefit everyone going forward. Our customers will also be subject to the new IVDR and will likely be worried about achieving compliance. Now is the time to show leadership and demonstrate a clear path to compliance which will ultimately increase trust in the whole market.
Watch now: Do you transform the challenges into opportunities?