Have you noticed that your friends in Regulatory seem a little frazzled lately?
There’s a good reason. On May 26, 2020 the new European Medical Device Regulation (MDR) goes into effect, and that means big changes are afoot for nearly every device company selling in Europe. Lest you think those changes affect only those poor souls working in Quality and Regulatory, think again.
While it’s true that Quality and Regulatory are probably the leading “points” on MDR implementation and integration, there are still some unknowns about the regulation.… » Read more
If you market an IVD in Europe and are just starting to think about doing a thorough gap analysis for the In Vitro Diagnostic Regulation (IVDR), it’s definitely not too early to start. An IVDD vs. IVDR gap analysis helps determine where you are now and where you need to be. While the EU IVDR entered into force in May 2017, the final date of application isn’t until May 2022. This is a longer transition period than for the EU MDR because the preparation phase will take longer for most IVD manufacturers – the changes in the IVDR are more significant and impactful than those in the EU MDR.… » Read more
With the publication of Europe’s new Medical Device Regulation (EU 2017/745) and In Vitro Diagnostic Regulation (EU 2017/746), some companies that contract manufacture or relabel devices (OBL/PBL) are wondering if they will be considered the “legal manufacturer” of the device they sell. Much of the confusion around this issue stems from the assumption that there can be only one legal manufacturer. The current Medical Devices Directive (MDD 93/42/EEC) and In Vitro Devices Directive (IVDD 98/79/EC) are not entirely clear on the issue, but their successors (MDR and IVDR) make it crystal clear: one device can potentially have multiple legal manufacturers and each one of these manufacturers may have regulatory responsibility for that device.… » Read more
While 2022 seems light years away, there are some really important reasons to take the IVDR seriously and start planning early…like now.
Here are some important things to consider.
1 – Conduct an Internal IVDR Gap Assessment ASAP
Yes, the IVDR implementation date of May 26, 2022 seems distant, but it’s definitely not too soon to conduct a robust assessment to see where you stand with regard to future compliance in Europe. A gap assessment is the first step and should answer these questions, among others: What classification will your IVDs have under the IVDR?… » Read more