The MDR extension is being written and spoken about at length, probably because it is a great idea to keep device supplies flowing in Europe and it gives the Notified Bodies some breathing room. But what about EUDAMED? What impact does the extension have?
The day after the delivery of the proposal by the European Commission I contacted them to find out how are the EUDAMED deadlines impacted. They responded by saying “the EUDAMED deadlines are unaffected”, again brilliant news. However, this proposal does bring some EUDAMED consequences for MedTech companies, which will directly affect some of their EUDAMED plans.
Within days of the proposal, we had clients coming to us who wanted to upload their legacy/directive devices. These are companies that had decided not to submit any legacy devices only to submit their regulation devices.
Why the change? The mandatory vigilance reporting of serious incidents in EUDAMED. When EUDAMED becomes fully functional in 2024 all serious incident reporting will be via EUDAMED, this is mandatory. To report an incident in EUDAMED the device must exist in EUDAMED, and you only have two days to report the incident. So prudent companies are not going to risk missing the two day deadline because their legacy device data was missing from EUDAMED, they are getting all the legacy devices into EUDAMED now.
As the extension will allow legacy devices to be sold up to 2027/2028 and beyond, from a risk management point of view it is safer to have these devices in EUDAMED way before EUDAMED becomes fully functional.
The extension, what is the big deal? Firstly, the selloff periods are removed for both safe medical devices and in vitro devices, this is a big win for the industry, no more having to dump perfectly viable devices. These devices must still comply with the directives and to gain the extension there are rules you must comply with:
- there can be no significant changes in design or intended purpose.
- the device does not present an unacceptable risk.
And as part of the extension compliance, we have new deadlines which could in themselves bring new bottlenecks
- A QMS is required before 26th May 2024
- A formal written application to an NB before 26th May 2024
- A signed agreement between NB and MF no later than 26th September 2024
This signed agreement is a big issue, do not underestimate the time it takes to get this agreement. I was a featured guest of J o e H a g e on his MDG Premium channel (medgroup.biz/premium) recently where Michelle Lott, RAC, a real MDR expert, said to get one of these signed agreements takes at least 9 months. I presume this is if things go smoothly and Notified Bodies are not overwhelmed with people wanting to extend the 100,000s of directive devices. Nine months minimum, in reality, this means if a MedTech company wants to extend the device they should start the process ASAP in order to avoid the guaranteed bottlenecks. You can be sure some companies will sit back and wait, only to find that Notified Bodies do not have the capacity to handle their applications for a device extension.
There are three ways you can get the extension, and this applies to “Certificates issued by notified bodies in accordance with those Directives from 25 May 2017 that were still valid on 26 May 2021 and that have expired before the extension regulation comes into force”:
1. before the date of expiry of the certificate, the manufacturer and a notified body have signed a written agreement in accordance with Section 4.3, second subparagraph, of Annex VII to this Regulation for the conformity assessment in respect of the device covered by the expired certificate
2. OR a completely new concept, and this is a very interesting one, an agreement in respect of a “device intended to substitute that device”. I presume the intention here is for a substitute device with the same intended purpose as the legacy device, however, the amending regulation does not say that so this is wide open for various interpretations. Can the devices be completely different and still get the directive device extension? Maybe the NB will have their own thoughts on this.
One last thought on the substitute, if you are going to substitute a product why would you work on the new regulations for the old directive device, why not simply leave this device on the market until the end of the extension and all in the supply chain are sold, and just work on substitute device meeting the regulations?
3. The final option for gaining the extension is if a competent authority of a Member State has granted a derogation from the applicable conformity assessment procedure in accordance with Article 59(1) of this Regulation or has required the manufacturer, in accordance with Article 97(1) of this Regulation, to carry out the applicable conformity assessment procedure.’;
Do not forget the warning that Michelle Lott, RAC gave, this process could take nine+ months so don’t delay.
Extension dates and Sell Off Period
The following are the dates of the extension if you have your NB agreement:
- 26 May 2026 class III custom-made implantable devices may be placed on the market or put into service until 26 May 2026 without a certificate issued by a notified body
- 31 Dec 2027 – Class III & Class IIb – implantable devices except for sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, and connectors.
- 31 Dec 2028 – Class IIb (other than those listed above), class IIa and Class I devices placed on the market in sterile condition or having a measuring function.
- 31 Dec 2028 – Directive devices for which the conformity assessment procedure did not require the involvement of a notified body with the declaration of conformity drawn up prior to 26 May 2021 and for the new regulations requiring the involvement of a notified body, may be placed on the market or put into service until 31 December 2028.
The amending regulation does prohibit, by the end of the transitional period, the further making available or putting in service devices that are still in the supply chain one year after the end of that transitional period.
- However, it also states, to prevent disposing of safe medical devices and in vitro devices that are still in the supply chain, to avoid shortages, should be unlimited in time.
- Final thoughts and remaining questions
- The European Commission said this is to alleviate device shortages and to help notified bodies manage the load. If they wanted to help notified bodies then why did they not provide them with machine-to-machine access for mass uploading of certificate data to EUDAMED rather than forcing them to manually add certificates?
- Does the sell-off period removal in conjunction with an extension, if you have the NB written agreement, mean manufacturing can continue right up to the final extension date?
- Other than the device labels ‘sell by date’, can these devices remain in the supply chain and on the market until stocks run out? For years?
- And the supply chain, is that a fully manufactured and shipped product? Or does this mean you have the parts in stock and ready for manufacture?
- If you are substituting a product how will this affect the supply chain stocks? Will legacy devices be in competition with regulation devices?
- Will notified bodies just make a big grab for clients knowing that it could be years before they can actually assess their products?
- How will these written agreements be policed?
We have been providing submission services for the past couple of years to many companies and uploaded thousands of devices, both directive and regulation devices. Our services can save you both time and money. We can provide you with a complete solution where we can collate your data, submit it to EUDAMED, and prepare procedures to support EUDAMED post-data submission OR we can simply provide you the submission software and our full expert support. The choice is yours; we are here to make EUDAMED as easy and painless as possible for you.