Gaining market access for in vitro diagnostic (IVD) devices is tough. Whether it involves seeking FDA 510K approval or a European Union CE mark, the underlying regulations are complex and stringent. Depending on the type and class of device and the country’s legislation, generating all the required quality management system documentation, scientific validity, analytical performance, and clinical evidence, can be both labor- and time-intensive.
Fortunately, help is at hand. Experts in regulatory affairs are available to guide manufacturers through the rough waters of market approval. Not only can they advise on strategies that cover an entire product portfolio, but they can also introduce neat tools to complete some of these steps in a more efficient way.
To find out more, we connected with Oliver Eikenberg, Global Quality Assurance and Regulatory Affairs Manager at Pure Global. Read on to hear what it’s really like working as a regulatory consultant, the common pitfalls to applications, and the new computerized tools that can help smooth the process.
Tell us about your career
I'm educated as a chemist, and gained my PhD in biochemistry around 2000 before I stepped into the medical device industry. After many years in the industry I moved to the regulatory quality and assurance side, where I spent the last 10 years.
After gaining experience as a research and development manager and a head of production, I redirected these skills into consultancy for IVD companies seeking more efficient documentation. Initially this was focused in Europe (MDD/IVDD, MDR/IVDR) but eventually I branched out into the US and Australian markets. My expertise covers all aspects of regulatory and quality affairs related to the medical device environment. As well as advising on the European IVD regulations (IVDR) and US 510K regulations, I'm also qualified as an auditor, supporting FDA inspections, or carrying out ISO 13485 or ISO 9001 audits.
After freelancing for a while, I moved to Emergo by UL, where I spent 10 years of my career as lead consultant for IVDs, before joining Pure Global in 2024 as quality and regulatory affairs manager for IVDs.
What does your current role involve?
My education as a chemist gives me a good background into the science behind IVD devices, and that helps me greatly in my discussions with manufacturers, suppliers, economic operators, notified bodies, and competent authorities.
My remit is to go beyond consultancy, and provide smart solutions to medical device and IVD manufacturers in gaining – and maintaining – market access globally. Pure Global provides a global service network covering 30 markets, with offices in 17 strategic markets worldwide. We have global expertise in these countries' regulations, as well as colleagues who support medical device manufacturers in certifications and approvals. We also have a large clinical team to carry out any specific clinical testing that is required. And, importantly, we use software tools and AI technology to develop and provide these smart solutions to clients.
This is important because, whilst we cannot change the complexity of the regulations, we can use intelligent solutions to make it easier to comply with them. Some work can require many hours of searching specific documents or creating submission documents, with a lot of redundancy. These tasks are much easier to complete using efficient software tools. That’s what marks our approach out from other consultancies, I believe.
What do you think the impact of new regulations might be on IVD companies?
Whilst the IVD regulations themselves are not new, updates come along that can significantly affect manufacturers. One of the most recent is the requirement for clinical evidence to support the intended purpose for the IVD device, as defined by the manufacturer.
Along with that, classification rules have been implemented for the first time for IVDs in the EU. These are based on the intended use of the device and its diagnostic risk for patients. Under the EU IVDR, there are criteria defined for an intended purpose. This means that many manufacturers need to include more details on their device.
Whereas classification requirements have been in place for the medical device field for many years, they are new for IVDs – and are still a significant challenge for many IVD companies. Further, the higher the IVD risk class, the greater the need to demonstrate clinical evidence through clinical performance studies with patients.
The solution is to have a good strategy and use smart tools to meet the requirements efficiently, to minimize the costs of making this transition.
Could these costly requirements limit the innovation potential of smaller companies?
For small and medium-sized companies, of course it could be a higher burden to comply with the regulatory requirements. This always depends on the IVD device and the status of regulatory compliance. Clients ask me if they still need to provide clinical evidence if they release only small numbers of a product. The answer is that the safety risk to patients is the same whether you make 10 products or 10,000. Regulations are written for the safety of patients and therefore you will never find these business questions reflected in legislation.
This is where smart tools can really help. For example, if you plan to introduce your product into 25 different markets, the instructions for use must be translated into 25 languages. Using our translation tool, the manufacturer can significantly reduce the time and cost of this process. With a simple click you can translate your documents. You still need to verify the final check through a certified translator, but save considerably on their initial generation.
Another example is the literature searches that must be performed as part of evidencing the product’s scientific validity. These are very time consuming when performed manually. We have developed smart software tools that can finish the search task in minutes and pre-appraise the literature from different databases. The regulatory experts then can focus on the final appraisal and content instead of spending hours in searching and formatting.
Generating the regulatory documents to submit to the authorities is also a huge undertaking. Our consultants are able to help generate smart strategies for this. If you have a few similar products, for example, you might be able to group them and create one document instead of multiples.
Consulting regulatory experts early in the product’s development can be incredibly beneficial. Consultants will scrutinize the company’s entire product portfolio and advise where they might have one risk management file or one postmarketing file to reduce the work. These sorts of efficiencies reduce the work and cost of market access, and make it far less burdensome even for small and medium-sized enterprises.
What trends are influencing the IVD market in the US and Europe?
The trend that’s gaining most news time at the moment is artificial intelligence (AI). However, the regulatory authorities usually include this under the banner of software. And it’s important to understand the definitions, because AI has its own legislation that is understandably more complex than the general software regulations.
In any case, it’s important to understand that both the medical or IVD device and its associated software need to meet regulatory requirements.
What are the main hurdles to gaining marketing approval for IVDs?
Demonstrating evidence for the clinical performance of the product is the most common stumbling block.
Typically, the higher the risk category of the product, the more likely it is that you need to do clinical investigations or clinical performance studies. For IVDs this is one of the biggest challenges because most of these devices are legacy devices or have never been audited or reviewed by a notified body.
I mentioned, before, the introduction of the new classification rules under the EU IVDR, which are aligned with the requirement to define the intended purpose according to specific criteria (target population, indication, manual or automated use, etc.). This new or clarified intended purpose may now impact the objectives for a clinical performance study to verify clinical evidence.
In some cases the notified body will simply ask for adequate clinical data that could be generated in-house from clinical samples. But quite often they will require data generated in a specific clinical setting. And then the question is whether this has been done under adequate ethical conditions.
I have seen hundreds of technical documentations which contain adequate data but they are not approved by a recognized ethical committee. Or the data are not approved by a national competent authority because they were generated in a research study rather than a clinical performance study.
In these cases, the results are unlikely to be considered as valid to support CE marking of the device – either for IVDR or IVDD. That can raise significant questions on the adequacy of current or future CE marking. In the worst case, the CE mark can be suspended and the company needs to restart the CE marking process.
What is your key piece of advice for IVD innovators seeking European market access?
If the manufacturers have adequately met the EN ISO 13485 quality management system requirements, collected the clinical evidence, have all the data on file, and are using established technologies, then they don't have a significant problem in transitioning to the IVDR.
The key is the delta between the state of the art, the regulations, and good preparation. It’s easier for the companies who have had devices on the market for many years that are controlled by notified bodies. They are already familiar with the higher level of control documentation and objective evidence required for notified body reviewers and they typically have a much lower time and cost when moving the products to the IVDR.
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