0:04 – 0:38 Natalia Farina, Business Assurance Global Marketing Manager
Hello and Welcome to Intertek Assurance in Action podcast!
My name is Natalia Farina, Global Marketing Manager for Business Assurance with Intertek, and I’ll be your host for this episode. Today we're counting down to a shift in the medical device industry: the transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR). Joining me is Curtis Riley, Head of Notified Body at Intertek Medical Notified Body – Business Assurance. Welcome, Curtis!
0:38 – 0:40 Curtis Riley, Head of Notified Body at Intertek Medical Notified Body – Business Assurance
It's a pleasure to be here.
0:41 – 0:51 Natalia Farina
OK, Let's dive right in. For those who might not be familiar, what exactly is MDR and what are the main challenges for manufacturers?
0:53 – 2:13 Curtis Riley
Let’s get started. So, MDR stands, as you said, for the medical Device Regulation, which is replacing the previous medical device directive of the MDD and the MDR. It's essentially a new set of regulations governing medical devices within the European Union. The main challenge for manufacturers is the increased scrutiny we're seeing under this increased regulation and that's the requirements for compliance.
Those changes include stricter regulations on clinical evidence, so the burden of evidence to be provided the post market surveillance and transparency throughout the component supply chain and the significance of the MDR for medical device manufacturers cannot be overstated.
This is a huge change to the industry and compliance with the MDR demands a comprehensive reevaluation of the manufacturers processes the device, technical documentation and the overall quality management system underpinning their conformity and the regulation it requires a more proactive and ongoing approach to conformity, involving that increased clinical data, having that robust quality assurance and running throughout a more sophisticated risk management strategy.
2:14 – 2:23 Natalia Farina
Yeah, that sounds like an adjustment. From a business perspective, how should manufacturers prepare for MDR?
2:24 – 3:10 Curtis Riley
Well, I think preparation really is the key to this and we're seeing manufacturers respond appropriately and manufacturers really need to plan and do a thorough review internally, updating their technical documentation to meet those new requirements and the quality management system underpinning their device conformity.
It will include doing a gap assessment, identifying areas perhaps where they're device may be not complying and ensuring that their products do meet those new then acquirements outlined within the annexes of the regulation.
It really is critical to engage with us, the notified body, early in the process to avoid any delays in certification between the MDD and the new MDR transition.
3:11 – 3:22 Natalia Farina
Yeah. Speaking of differences, let's talk about the discrepancies between MDR and MDD in terms of enforcement. Can you walk us through the main differences?
3:23 – 5:19 Curtis Riley
Certainly it's a, it's a pretty comprehensive change.
If we look at the size of the previous Medical Device Directive and the new regulation, there is a many, many hundreds of pages of differences.
But if we look at some of the key ones, it's more reliant on the burden of evidence in the technical file.
Previously, under the Medical Device Directive, it relied on self-certification and the assessment by a notified body and the MDR now builds on that, imposing stricter controls and oversight by the competent authorities who designate the notified bodies and the notified bodies performing their assessment.
You ask about some of the changes - the MDR has more rigorous premarket scrutiny. That's for the high risk devices, including safety, demonstrating the evidence of safety, it expands the scope, including certain aesthetic devices, ensuring consistent standards between these devices for the first time, previously outside of the previous directive.
We're seeing a new database. The ultimate database has been established for providing traceability for manufacturers, notified bodies and competent authorities to understand the certification status of certificates and those that have been withdrawn.
It also introduces implant cards. That's to empower patients with device information.
Most critically, the MDR strengthens the rules on clinical evidence and post market surveillance activities. And as I said, it enforces that improved coordination between the European countries for vigilance and intervention when devices may be causing harm.
In summary, this means that manufacturers can expect a much more rigorous inspection and screwed any of their products throughout the lifecycle of the device over their certification period.
5:20 – 5:49 Natalia Farina
Thank you, that's an important distinction. Now, let's do a quick recap of the MDR timeline. As we know the new MDR Deadline for legacy devices has been moved to 2027 / 2028 – can you help to clarify what qualifies as a ‘legacy’ device and how the transition extension works for each of these devices?
5:50 – 8:29 Curtis Riley
Certainly, it's certainly a complex transition.
If we step back and look at the history of the regulation, we know that was published in April 2017 and this adopted the Medical Device Regulation that replaced those the previous, AIMDD and the MDD directives. So the new MDR is the current standard regulation requirement for manufacturers to meet.
And last year we saw that the MDR as published in 2017 was amended.
By amending Regulation 2023 #607 and this is an important document, it allows the previous MDD certificates to be recognized as valid even beyond the dates indicated on the certificate, that's so long as certain conditions are met in the regulation. The legacy device is one that was previously certified against the Medical Device Directive and these devices, in accordance with the MDR traditional provisions were placed on the market before when the date of application for the MDR became effective, May 2021, when new devices need to meet their requirement.
So the transitional period, as you say, was originally scheduled for May 26th this year and it's been extended to the 31st of December 2027 or 2028 depending on the risk class of the device.
For 2027, it's for the higher class devices: the Class 3 devices, the Class 2B implantable that some exceptions to that.
For December 31st, 2028, it's for the lower classes of devices classes to be other than those exceptions, the class 2A's and the class ones.
So depending on the classification of the device, you have a different date that the legacy devices are permitted on the market.
So for this, the manufacturer needs to submit an application for EU MDR certification before the 26th of May 2024, so a date fast approaching. The manufacturer can self-declare the extension that their quality management system is in conformity of the regulation and submit a change note to us.
If they weren't, if they wish to have a confirmation letter confirming that we're taking responsibility for this events, activities, the next key date is the agreement.
There must be signed between us and the manufacturer and there must be signed by the 26th of September for that legacy device extension to be continued.
8:29 – 8:40 Natalia Farina
Already. What can a medical device manufacturer do to ‘prove’ that their device is a valid legacy device under the extension?
8:41 – 9:45 Curtis Riley
Yes, the amending regulation, it's pretty clear on this. It outlines the requirements for the manufacturer to self-declare and there's a template that's been developed and it's now made available by the medical Device Industry Association, and that can be find on the MedTech Europe website.
It's basically a declaration, it is to provide the opportunity for the validity of certificates issued under the previous directive and the compliance of the manufacture of the direct of the device for the conditions for the placing of the product on the market in the service. We're seeing an increase of request of this.
Manufacturers are requesting the confirmation letter from the notified bodies and the notified body confirmation letter is the document demonstrating that the notified body has taken ownership of that continued surveillance and it's accepted by regulatory authorities, including some outside of Europe.
Some manufacturers are expecting to see a new certificate being issued. That's not the case, it's this letter of confirmation that provides that eligible extension.
9:46 – 9:59 Natalia Farina
It sounds like a complex situation. Can you speak about the kind of changes that can be made to a device without impacting its legacy device status?
10:00 – 11:42 Curtis Riley
Certainly, manufacturers can make non-significant changes. That's changes that do not affect the intended use or significant changes to address a specific safety concern that will be followed by some sort of vigilance or similar report.
In the regulation, if we look at Article 120, it talks to those transitional arrangements, and we have the additional guidance document now the MDCG 20-23 providing a summary of what is considered significant change. It's all significant changes that are not permitted to legacy devices.
It's worth taking a look. There's some very helpful flow diagrams for manufacturers to follow changes to intended purpose, or it would be something like being used on new patient population, a new a new patient group.
Maybe there would be a new clinical use. These are all suddenly be considered significant against Article 120 and not permitted.
There's also a flow diagram for design, there's one for software, also materials and sterilization methods.
So, it's really worth taking a look at that guidance document to help and certainly contact the notified body early ahead of making that change, so we can discuss this before making any planned changes.
Often we're asked about the administrative changes of an organization.
In principle, they're considered to be nonsignificant changes, like the manufacturers name address, the legal status, the employee headcount, or the authorized representative, this would not be considered significant.
So, really, engage the notified body early, inform us about the change using our change note process and we can discuss that ahead of implementation.
11:43 – 11:54 Natalia Farina
Absolutely. Considering the timings for legacy devices, would a manufacturer still be able to use the extension if they don’t plan on marking under the MDR?
11:55 – 12:24 Curtis Riley
Good question. No, if the manufacturer is not intending to place the product on the market under the MDR, they would not be eligible for that extension.
The manufacturer needs to have submitted an application under the EU MDR by the 26th of May and sign the agreement by the 26th of September. Remember, the notified body will continue MDD surveillance has an ongoing activity during that extension period whilst they're completing their MDR application.
12:25 – 12:33 Natalia Farina
Alrighty. And can you speak about some of other complexities associated with MDR?
12:33 – 12:59 Curtis Riley
It's actually one of the biggest complexities is the application process itself, the preparation we spoke about before, manufacturers being required to submit a comprehensive technical documentation package to us to review for certification and this can be a time consuming and resource intensive process especially for companies with a limited internal regulatory expertise.
13:00 – 13:05 Natalia Farina
Can you tell us more on how Intertek can help with this transition?
13:06 – 14:04 Curtis Riley
Yeah, so, Intertek: we offer a range of services to support manufacturers throughout their transition process, including a new pre-assessment service without consulting as that's not permitted under the regulation. As part of the application for conformity assessment, and as part of the submission, we can perform a pre-assessment and that will identify areas of concern and we'll document that in the way of nonconformities that can be addressed before the subsequent final review, giving the manufacturer the opportunity to resolve this before that final assessment.
Our team of experts throughout that and the application process throughout the conformity assessment, we can provide assistance explaining the nonconformities and the next steps every step of the way, really helping companies navigate it is complex through the complexities of the MDR to achieve market access as efficiently as possible.
14:05 – 14:10 Natalia Farina
That's great. And what are the next steps of the MDR application process?
14:11 – 15:33 Curtis Riley
So, it all starts with that pre-application. During that phase, we ask the manufacturer to provide basic information about their company and the devices, the device list, and the client information form.
Internally, we then review this information to prepare the proposal and the regulatory and commercial agreements, and this is based upon the information provided in that pre-assessment and we'll prepare that proposal. After signature, once the proposals been signed will kick off that formal application and it's during this final step that we're performing our assessment, thoroughly reviewing the technical file, all of the evidence provided and that will be in English and after the technical documentation review, we performed the stage one and the stage two audits on site at the manufacturers.
Any non-conformities that are issued or discussed, it's important that they understood and we unsure understanding for the subsequent corrective actions that are taken by the manufacturer and the follow-up reviews to close out those findings.
But it's not just the MDR, we're helping manufacturers at the moment, the notified body and Intertek Business Assurance offer the combined audit solution with accreditation that designation for ISO 1345, the Medical Device Single Audit Program (MDSAP) and UKCA certification.
15:34 – 15:56 Natalia Farina
That's fantastic to hear. Curtis, thank you for sharing your insights on this important topic to the medical industry. To all our listeners, if you have any questions regarding MDR transition, please reach out to IMNB@intertek.com. Until next time! Goodbye.
