Gearing up for the IVDR era – The regulatory viewpoint

The European In Vitro Diagnostic Medical Device Regulation (IVDR)(EU) 2017/746  is upon us and will touch our lives in many ways. In an insightful chat with our team, Manoja Ranawake, VP Regulatory Affairs, BD, spoke about the IVDR, and how it is going to impact both manufacturers and customers alike. 
 

1) How does a large company like BD, covering both the Medical and the Life Science businesses, look at the MDR – IVDR changes?
 

That’s a very broad question, but also a good one because if you look at how the regulations were developed, in vitro diagnostic medical devices (IVDs) tend to follow what has happened with medical devices. Medical devices were much more highly regulated in the past under the Directives compared to IVDs. Also, just bear in mind that BD is one of a handful of companies that does both medical devices and IVDs, so it is more challenging and more complex for us as a company. In the past under the European In Vitro Diagnostic Medical Device Directive 98/79/EC (IVDD), only about 5% of our entire portfolio required the intervention of a notified body (NB) to get our products onto the market. But now, under IVDR about 75% of our devices need a certain level of intervention from an NB to put them on the market. So, it is more complex, and also financially, there is a big impact on us to get our products IVDR-compliant. There are also ongoing costs for us as a company to maintain the product once it is on the market. But as the regulations are largely very similar for medical devices and IVDs, we have applied our knowledge and experience in medical devices requiring the intervention of an NB to IVDs as well. We already have the majority of the knowledge which we can tap into, to get our products compliant under the IVDR.

2) From a manufacturer's point of view, how many different stakeholder functions are touched by these regulations?
 

Pretty much every single function, from R&D to product marketing, is hugely impacted by IVDR. It also has a major impact on us when it comes to manufacturing. The Quality Department is also impacted.  Care has to be taken in how we interpret every aspect under IVDR. Medical affairs are impacted as well because clinical evidence is a huge component in what is required to bring our products on the market.

3) How will the IVDR affect BD’s portfolio and how well are we prepared to deal with the IVDR?
 

It is a big challenge for us as a company but is also a huge opportunity for us in terms of how we set up our portfolio and how we serve our customers. It is about optimising and streamlining our portfolio, simplifying our processes about how we bring our products onto the market. As a company, we have a huge portfolio of products so we have to look at what we want to keep on the market in terms of what is performing well, what is serving our customers, and what is bringing in revenue as well. That being said, we are heavily investing in providing patients and customers with the best possible solutions. So we will meet their needs in terms of what we have to do under the IVDR.

4) How long before the date of May 2022 did we start working around IVDR and how do you expect the business(es) to be positioned by May 2022?
 

The IVDR text was published in May 2017, and there were draft versions of the text available two years before that. BD started looking at the draft text, and since the final version was published in 2017, we have been actively looking at what we need to do as a company. So, we have started, back then, to consider what the impacts would be for us and what we need to do to implement the IVDR requirements across our company.

5) What are the challenges that you see standing out?
 

One of the biggest differences with what was happening under the IVDD compared to what is now happening under IVDR is with regards to clinical evidence. Every single device, from the lowest class to the highest class has to have some level of clinical evidence. So, the higher the risk the more efforts are required to bring the product on the market. That involves quite a big change. It had already started happening with medical devices before the MDR was published.  But now it is at the forefront in terms of what we need to do to bring a device onto the market and to maintain the device on the market. The system, required to bring products onto the market and make them compliant under the IVDR, has still has not been completely established. The number of NBs out there is quite small. I think there are about six, at the moment. There were more than double that under the IVDD. So the number of NBs has reduced, but the number of manufacturers has largely stayed the same, resulting in a severely reduced NB capacity. The NBs that we had been previously working with for IVDs are certified under the IVDR, but their capacity is also taken up because many other manufacturers want to bring products onto the market. We need to make sure we are submitting everything on time and having that time to get the reviews completed and have our products certified under the IVDR.

6) What role is BD Regulatory Affairs playing in helping the company prepare for and implement the new IVD regulation?
 

In terms of having the product CE-marked, under the IVDR, that responsibility sits with the legal manufacturer and these are mainly based in the US. My team in EMEA has regional responsibilities when it comes to the IVDR. We are engaging with the trade associations, advocating our position as a manufacturer to ensure that everything works well in the EU system for us to get our products on the market. So, we are working with our stakeholders and customers to ensure that we are meeting their needs, and then advocating our position through the trade associations to the European Commission so they understand what we need to do as a company in serving our customers. Some people outside the European Union may see the IVDR as a barrier, but it is not so. It is bringing more robust safety for patients, for the products they use. It brings a differentiation for the European Union on the single market. The IVDR is something completely different from what is done in the US with FDA, China or Japan, or anywhere else. It is unique in that sense. It helps us to differentiate ourselves, not just in Europe but also in the global market.

7) Can you tell us how our customers may be impacted by the IVDR?
 

When we look at the impact of IVDR on customers, you could say it is threefold. The continuous availability of established products and potential amendments to the product claims may change with the IVDR. As we move from the old directive to the IVDR, there may be some impact. There may be certain restrictions on conditional use, for example, with assays, and how they do that. There is also the EUDAMED, the EU database for medical devices, which will provide an overview of all CE-marked medical devices, product groups, information related to safety and performance. All this information will be at their fingertips so they can access it very readily. So customers will be able to make informed decisions like never before. It is quite a big change and needless to say, BD will strive to make that transition as smooth as possible for our customers.

Visit our dedicated IVDR page.