In recent years, regulations for medical devices have evolved significantly. The Medical Device Regulation (MDR) has been taken into effect, and in tandem, the In Vitro Diagnostic Medical Device Regulation (IVDR) has replaced the preceding IVDD.
The new regulations MDR and IVDR, have elevated the level of requirements, adding emphasis on clinical evidence and a higher degree of involvement from notified bodies in the certification process. In addition, the new regulations require a more robust post-market surveillance process and the risk-based classification system for devices has been changed, which means that devices that before were considered as low risk now fall under higher risk classes. Such changes pose challenges for manufacturers of medical devices and especially for manufacturers of IVD devices previously certified under the IVDD, where the majority of devices now must undergo reapproval certification including notified body review.
In this article, we dive deeper into these challenges, and the Key2Compliance team share their valuable insights and advice. The article explores difficulties posed by the new regulations and presents strategies that medical device manufacturers can utilize to overcome them.
Maria Lindgren, Johanna Fugelstad, and Robert Iosif, leading members of our clinical development team, share their expert perspectives. Their combined experience in clinical evaluation, clinical investigation, and clinical development offers invaluable resources to any medical device manufacturer navigating the new regulations.
As previously mentioned, one of the biggest challenges brought about by the MDR and the IVDR is the more rigorous requirements for clinical evidence; meaning testing on humans in a clinic/hospital setting. The new regulations place a much greater emphasis on the use of clinical data in demonstrating the performance and safety of medical devices. This is particularly challenging as collecting data and conducting clinical studies typically take a lot of time and incur additional costs.
A clinical evaluation is required as part of the technical file for the device. Companies who are struggling with understanding which level sufficient clinical evidence is needed for their product will benefit from a clinical evaluation done EARLY and by experts to see where they are lacking, or to eliminate uncertainties regarding the adequacy of available data.
If the clinical evaluation team finds that there is a lack of data to support the safety and the performance of a medical device, as compared with best practice/ state-of-the-art in the relevant medical field, further collection of data must be done to ensure that there is enough clinical evidence. “The clinical evaluation process assesses if the clinical evidence is enough to provide support for the performance and the safety of the device. If there’s a gap, there needs to be a collection of new data,” Johanna Fugelstad, Manager Clinical Evaluations, says. Depending on the risk class of the medical device and the degree of clinical evidence, the data can be produced through small-scale post-market surveillance, or if needed a full-scale clinical investigation.
This, however, is just one of the new challenges brought about by the new regulations. Medical device companies also need to be aware of other potential difficulties under the new MDR and IVDR, as these can also hinder the CE-marking process.
Naturally, the new MDR and the IVDR also apply to older (legacy) medical devices that have already been approved and are available in the market. Depending on the classification of their product, companies are now required to update these in accordance with the new regulations, and they must do so under a specific timeline.
Furthermore, the whole process can also be delayed due to the limited capacity of notified bodies. Under the new regulations with the change to risk classification rules, many more device manufacturers need a notify body, and with a limited number of notified bodies available, companies may have difficulties in finding qualified notified bodies for their specific product.
Another common error committed by medical device companies is skipping out or missing out on important steps in the process. Maria Lindgren, Director of the Clinical Development team, says that as experts, they can help companies realize where they currently are in the process, and then help them reach their goal. “We understand that they might have missed some steps and have jumped ahead. We need to help them find where they currently are, and where they should go,” she says.
Many companies only consult experts once their application has been submitted and then rejected. Most of the time, this can incur more costs and waste more time due to the gaps in the process.
Robert Iosif, Manager Clinical Investigations, emphasizes that the sooner medical device companies approach consultants, the smoother the process will be. “When we help them design the study, we notice that the clinical evaluation was not done properly, which means that they will have to go back and redo it, or it has an implication on the study design, resulting in a much more expensive and complicated study. This could have been easily avoided if they approached an expert for a proper clinical evaluation in the initial phases of the project.”
Maria Lindgren also highlights that one of the biggest strengths of the clinical development team of Key2Compliance is their specific and tailored approach to the process, depending on the needs of the medical device companies. They typically take on the most reasonable approach to help the manufacturer reach their goals. “Our strength is that we have so much experience and have helped so many different companies. We tailor our solutions according to the company and their device. We find the smarter solutions and the approach that will work best.”
Robert Iosif, further adds that the clinical development team at Key2Compliance takes on a synergistic approach, with different teams specializing in different areas of clinical development. This collaboration between the different groups under the clinical development team allows for a more seamless approach, with each team complementing the other. “We have competence in different business areas. This dynamic allows us to easily find all the pieces of the puzzle,” he says.
While the challenges presented by the new medical device regulations may seem initially daunting, guidance from consultants and industry experts can help companies navigate and overcome these hurdles. Key2Compliance delivers tailored and specific solutions depending on the needs of a medical device company.
Key2Compliance’s clinical development team is composed of several experts with extensive experience in their respective industries and backgrounds. They are equipped with the knowledge and expertise necessary to assist medical device manufacturers in the overall process of advancing a medical product from its early stages of research to its approval and use.
Maria Lindgren, Director of the Clinical Development team, provides consultancy services relating to clinical evaluations and clinical investigation documentation. She holds an MSc in Chemistry and a PhD in Neurochemistry from Stockholm University in Sweden. While Maria’s main expertise is in clinical evaluation and clinical investigation of medical devices, she also has extensive experience in drug and medical device development and research.
Working within Maria’s team is Johanna Fugelstad, Manager of the Clinical Evaluations team. She holds a PhD in Biotechnology from KTH Royal Institute of Technology, as well as an MSc in Molecular Biology from Stockholm University, Sweden. Johanna has extensive knowledge in life science research and in the medical device industry. Her experience ranges from product development for in vitro diagnostic point-of-care products to regulatory compliance for software classified as a medical device among others, with a main focus on clinical and performance evaluations.
Robert Iosif, Manager of the Clinical Investigations team, holds an MSc in Molecular Biology from Uppsala University and a PhD in Neurobiology from Lund University in Sweden. Previously, Robert has also worked on drug and medical device development and research, project management, and regulatory documentation.
Our team of clinical development experts can help you find the specific approach you need to meet your goals, wherever you may be in the clinical development process! Contact our experts today!
