The Window for Renewing MDD Medical Device CE Certificates is Quickly Closing.
- Oriel STAT A MATRIX
- 0
- on Aug 19, 2018
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 exacerbated 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.
| DEVICE CLASS | COMPLETE NEW MDD/AIMD SUBMISSION |
| New CLASS III or AIMD CE submissions* | No later than March 2019* |
| New CLASS IIb MDD CE submissions | No later than May 2019 |
| New CLASS IIa MDD CE submissions | No later than July 2019 |
| New Class I Sterile or Measuring MDD CE submissions | No later than August 2019 |
*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 that did not scare you into immediate action, this might: Another major Notified Body has told its clients that it will stop certifying to the MDD 3 months after it achieves MDR designation in Q4 2018. That means this particular NB will not be renewing/issuing MDD certificates beyond early 2019! Jump to it – other NBs are likely to present similar deadlines.
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.
| TYPE OF AUDIT | COMPLETE AUDIT BEFORE… |
| CE renewal audit, normal certification cycle | No later than May 2019 (we recommend now!) |
| CE renewal audit for certificates expiring after July 2022 | December 2019 (we recommend much earlier!) |
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
| CE Certificate expires | April 2019 |
| Renewal options | MDD only because Notified Bodies will not be certified to MDR until summer 2019, after current certificate expires. |
| When to start | Begin the renewal process now and allocate 3 months for renewal. |
| Important to know | MDR certificate must be acquired when renewal MDD certificate expires but no later than May 2024 |
Scenario 2 – Device has Existing CE Marking Certificate
| CE Certificate expires | September 2020 |
| Renewal options | MDD or MDR |
| When to start | Begin the renewal process now and allocate 3 months for renewal. |
| Important to know | If choosing MDD path: recertification audit should be completed before May 2019. No significant changes can be made. If choosing MDR path, certificate should be acquired prior to July 2020 to allow some cushion before certificate expires in September 2020. |
Scenario 3 – Device has Existing CE Marking Certificate
| CE Certificate expires | March 2022 |
| Renewal options | MDD or MDR |
| When to start | Begin the renewal process now and allocate 3 months for renewal. |
| Important to know | If choosing MDD path, recertification audit should be completed by December 2019 and preferably before. No significant changes can be made. If choosing MDR path, certificate should be acquired before December 2021 to allow some cushion before certificate expires in March 2022. |
Scenario 4 – File A New* CE Marking Submission
| CE Certificate expires | Not applicable, new submission |
| Renewal options | MDD or MDR |
| When to start | ASAP! |
| Important to know | If choosing MDD* path, certification audit should be completed before March – August 2019, depending on classification. We recommend starting now! If choosing MDR path, audit must be completed after summer 2019 and before the May 2020 deadline. Schedule now! |
* Important note: If you manufacture a Class I device that is NOTsterile, does NOThave a measuring function, is NOTa 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.
Oriel STAT A MATRIX can help with your EU MDR transition
Managing the transition from the MDD to MDR requires a lot of work, but you don’t have to tackle it all alone. Oriel STAT A MATRIX has helped dozens of companies with MDR gap assessments, CER reviews and more. If you are having auditing responsibility in your organization, consider this MDR auditing class as well.
