European Union: The countdown until the EU Medical Device Regulation (MDR 2017/745 EU) takes hold in late May 2020 is heating up. While 2020 seems like a long way off, a sizable reduction in overall Notified Body capacity will be exasperated by an equally sizable increase in demand for their services.
This means medical device companies that wait too long to renew or submit new MDD applications will pay a heavy price.
Many major Notified Bodies will not be designated to the European MDR until sometime between June and October 2019, just 7-11 months before the MDR goes into effect.
Once that happens, EU Notified Bodies will surely direct more of their resources toward the tsunami of MDR applications that will occur thereafter. This means that if you want to submit a new MDD submission or renew your existing CE certificates under the Medical Devices Directive (93/42/EEC), you might be out of luck if you don’t get on your Notified Body’s radar soon.
A major EU Notified Body is offering this advice to its customers regarding new MDD submission due dates
One of the larger European Notified Bodies is sharing this information with their clients about when the clients need to file new CE submissions in order to beat the May 2020 MDR deadline.
*Class III or AIMD submissions requiring consultation should be submitted before January 2019. Examples are products such as, combination products or those containing animal tissue.
If you are renewing MDD certificates, try to do so no later than spring 2019
Similar time constraints face companies looking to renew their existing MDD medical device certificates in advance of the May 2020 MDR cutover. Again, here is what that same Notified Body is telling its clients about MDD renewals.
It’s important to note that you need to COMPLETE your audit by these dates, which means you need to get that audit scheduled asap! We consider these dates to be “last minute” dates and highly recommend that you start much earlier…like right now.
Of course, another caveat with all of these deadlines (and note that these are deadlines from only one Notified Body) is that you better have solid documentation in place. If your CER, for example, isn’t top notch, the resulting delays in your response may doom your MDD submission or renewal.
Four practical examples of MDD vs MDR certification options
SCENARIO 1 – DEVICE HAS EXISTING CE MARKING CERTIFICATE
SCENARIO 2 – DEVICE HAS EXISTING CE MARKING CERTIFICATE
SCENARIO 3 – DEVICE HAS EXISTING CE MARKING CERTIFICATE
SCENARIO 4 – FILE A NEW* CE MARKING SUBMISSION
* Important note: If you manufacture a Class I device that is NOT sterile, does NOT have a measuring function, is NOT a reusable surgical instrument, and will NOT be reclassified under the MDR, you must comply with the MDR.–
Give your Notified Body at least 4 months’ notice, preferably more
Regardless of whether you will be renewing an MDD certificate or making a new submission under the MDD or AIMD, you must give your Notified Body adequate notice. Don’t expect that you can get everything ready and then submit a month later – it’s just not going to happen.. Again, all EU Notified Bodies will be swamped and so you really need to make a reservation and maintain regular communications as early as possible. This will also give you a hard deadline for motivating your team and getting things done internally. Explaining why you were not able to secure your MDD certificate is not a conversation you want to have with senior management.
Above information takes reference from:
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