Compliance & Regulation

IVDR Common Errors: Navigating Notified Body Expectations

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In this blog, we recap our webinar, “IVDR Common Errors: Navigating Notified Body Expectations” – Click HERE to watch it in its entirety.

IVDR Common Errors: Navigating Notified Body Expectations

Explore the notified body process and IVDR technical documentation with experts Margot Borgel, Director of IVD Global Regulatory Affairs at RQM+, and Vincent Balgos, Director of Medical Device Solutions at Jama Software®.

You will gain a thorough understanding of these topics and more:

  • The notified body’s approach to technical reviews
  • Key considerations from the notified body’s perspective
  • Common mistakes made when compiling technical documentation

Below is a preview of our webinar. Click HERE to watch it in its entirety.

The following is an abbreviated transcript of our webinar.

IVDR Common Errors: Navigating Notified Body Expectations

Margot Borgel: Hello, everybody. I am Margot Borgel. I’m the Director of IVD Global Regulatory Affairs for RQM+. My role at RQM+ is to support clients in their IVD regulatory journey. So this includes making sure that our projects are meeting regulatory requirements, and providing regulatory leadership to other RQM+ consultants and CRO team members. I provide regulatory support and guidance through the entire product lifecycle from design concept through clinical studies, regulatory submissions, and approvals.

A little bit about me is that I joined RQM+ after four years at BSI Notified Body, where I was a member of the IVD technical team, specifically working on IVDR, IVDD, and UKCA certifications. I’ve worked with many different IVDs across most technologies and many, many device manufacturers. Prior to that, I spent about eight years in the industry for an IVD manufacturer. In that organization, I performed duties in research and development, manufacturing, technical support, and product transfer, as well as manufacturing.

Just a little bit about RQM+. RQM+ is a global MedTech service provider, that provides expertise across the full product lifecycle for both medical devices and IVD companies. We provide end-to-end solutions across the complete medical device product life cycle. And that includes many different aspects of the MedTech life cycle. We have a variety of different business units that support different projects, so regulatory and quality consulting, laboratory services, clinical trial services, reimbursement, and technology as well with our Fern.ai solution.

So we’re here today to talk mostly about IVDR technical files. So we’re going to first go through IVDR technical review and certification by the Notified Body. Then we’ll get into how a Notified Body is going to approach a tech file review. And common errors that are seen during that technical file review process.

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Borgel: Okay, so the first thing we have to do before we can really get into this is talk about the IVDR transition timeline. So the timelines have recently been updated. They were approved a few weeks ago by the EU Commission. And so I’m just going to go through those very quickly. We have a date of application which passed 26 May of 2022. We’re about two years past that now. But there is some transitional provisions for devices that are currently certified either by the Notified Body or self-certified under IVDD with a declaration of conformity signed before that May 2022 date. So, basically, from the last transition provisions, everything has been pushed out by 2.5 years.

So for Class D devices and devices with existing IVDD certificates, the new transition deadline is the 31st of December 2027, and then each class is pushed out another year. So Class C is 31st December 2028, and Class B and Class A sterile are 31st December 2029. But there are some provisions that come along with this. The main one that is brand new is that you must lodge a formal application with a Notified Body two and a half years before those final deadlines. So May 2025 for Class D and existing IVDDs. May 2026 for Class C and May 2027 for Class B and Class A sterile. On top of that, there are some other provisions, mainly that you must be complying with the IVDR PMS and vigilance requirements as of the 2022 date of application. You cannot put any new products on the market except under IVDR. All Class A devices must be IVDR compliant. And then, recently added, is that you must have an IVDR-compliant QMS system in place by May of 2025.

Okay, so as an IVD manufacturer under IVDR, there are a lot of obligations for manufacturers. This is covered in Article 10 of the IVDR. One of those requirements is that you will maintain and keep up-to-date technical documentation for your device.

And so what does that look like? The requirements are pretty consistent across classes, with a few differences as you have lower-risk and higher-risk devices. But for all devices, you must have that compliant QMS system. You must have a tech file meeting Annex II requirements. And you must meet all of the GSPRs. You must have a performance evaluation plan and report and PMPF plan. For Class A devices, you’re self-declared so you don’t have to worry about Notified Body requirements. But all other devices, from Class A sterile up to Class D, require a Notified Body assessment and certification. Class A and Class B devices need a post-market surveillance report, whereas Class C and D need periodic safety update reports. The difference in content is pretty small, but there are some differences in where you put those documents, who you provide them to, and things like that.

And then Class C and D also require a summary of safety and performance. If you have a companion diagnostic that would fall under Class C, you’re also going to need to do an EMA consultation for that CDx. And for Class D devices, you’ll need to adhere to common specifications, or potentially go through expert panel review. And you’ll need to interact with the EU Reference Labs, which includes product verification and batch release.

This slide is just an overview of all of the technical documentation that is required under IVDR. I’m not going to go into every single thing on this list right now, but that’ll be here for your information. And it’s mainly covered in Annexes II and III of the IVDR.

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Borgel: Okay, so, now, I’m going to talk a little bit about Notified Body processes. Each Notified Body is going to have its own nuance to this process, but this is generally how it will go. So you, as the manufacturer, will submit your application to the Notified Body. There will be some back and forth there as you talk about your devices, what classifications they are, what kind of groups are going to get set up, and things like that. And once that’s all situated, you will sign a contract, and then you’ll be officially under contract with the Notified Body. They will do what’s called an application review. This is covered in Annex IX of the IVDR. They’ll basically just make sure they have everything that they need, that they agree with the classifications that you’ve provided, that they have assigned the right codes to your devices, and things like that.

After that is complete, the actual conformity assessment activities will start. So QMS audit and technical review, different Notified Bodies are going to do this slightly differently. Some don’t have any constraints. They can do one or the other at the same time, separately. There are no contingencies. Others have some requirements that the QMS audit happen either before or after the tech review, or that you have to have certain aspects of your technical file complete before the QMS audit occurs. And that’ll be something you’d discuss with your Notified Body. Once those two things are complete, there’ll be a certificate recommendation and then some sort of a review and approval process. So this is like a panel review at some Notified Bodies or a decision-maker review. And then, after that, the certificate will be issued.

When we break down that technical review into a little bit more detail, this is what it looks like. So you submit the documentation to the Notified Body. Most Notified Bodies do what’s called a completeness check, where they just look at what you’ve submitted and make sure they have all the documents they need, and sort out any deficiencies. If it’s a Class D device, you’ll need to make sure that you’re meeting certain requirements for those. So, mainly, have you met common specifications, or is it a first-of-type Class D without common specs? So then we’ll get into tech review. That will go through three rounds of questions, typically, for most Notified Bodies, where you’ll be able to resolve deficiencies in your technical file. That’ll go back and forth. While that’s happening, if you do have a Class D, that first-of-type expert panel review process will be ongoing.

CLICK HERE TO WATCH THIS WEBINAR IN ITS ENTIRETY:
IVDR Common Errors: Navigating Notified Body Expectations

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