It has been a very busy year for our Medical Device Division, which has already, since its conception last year, supported 38 different companies with projects ranging from companion diagnostics, drug device combination products, borderline classifications to full CE classifications. Of course, the number one topic has undoubtedly been the new European medical device regulation (MDR) and the NDA team have been working hard to provide clients with clarity through the change and help them get their important products to the market.
NDA launched its Medical Device Division in March last year to support drug development and medical device companies under pressure from increased regulatory requirements. Dr Tina Amini, formerly Head of Notified Body and Certification Authority at LRQA, was appointed to lead the department as Director, Medical Device Division and has been governing its progress during this first year.
“Setting up a Medical Device Division at NDA was primarily in response to the impact of MDR”, Tina explains. “This brought on an increased demand among existing clients, as well as requests from new med tech companies needing support to become compliant with the new regulations. The industry needs help navigating through these new procedures and this was an opportunity to bring together the expertise to do just that. The biggest reward, without a doubt, is to complete the process and get it right the first time”.
She continues: “When I accepted the role, I planned to start connecting with people in the industry, in face-to-face meetings, but due to the pandemic I had to establish the division remotely, both with the clients as well as my colleagues. This has been the biggest challenge for me during this first year.”
A challenge which Tina has proven she is capable of tackling. Of the 40+ projects that NDA has been involved with, 65% are completed to date and the team is particularly proud that they supported a successful CE certification in less than six months, which might be considered a record.
“The challenges we have faced over the last year varied from obtaining a full CE certification under MDD, support with approvals / variations for both med tech & pharma before MDR comes into effect, to updating clients’ quality management systems and technical documentations to meet the new stringent requirements, Tina states.”
How medical devices are brought to and maintained on the market has and will continue to substantially change. The implementation of MDR is a challenge, but in the long-term perspective it should lead to safer and better performing products in the market as well as a more harmonised approach by the Member States and the Notified Bodies. As the regulatory landscape for devices transforms, Tina has shared her knowledge and expertise through mentoring the industry through the new MDR landscape via different platforms and events, delivering trainings for different organisations as well as creating an easy to follow five-part training webinar series, Are you ready for the new EU Medical Device Regulation? which addresses several hurdles accompanying the new regulation.
The current challenges will not disappear anytime soon as ultimately all devices need to be certified against the new regulation. The number of medical device certificates due to expire by May 2024 threatens to overwhelm notified bodies. With a marked decrease in the availability of MDR designated notified bodies, there could be a major bottleneck when the transition deadline approaches.
Tina predicts “Looking to the future, in addition to the transition to MDR, the next major challenge for the industry will be the implementation of the new in vitro diagnostics regulations (IVDR). As of the 26th of May 2022, both new and existing in vitro diagnostics medical devices must meet the requirements to be placed in or stay in the European market. This leaves me with several concerns:
- Is the industry ready to meet the IVDR requirements particularly in the absence of the relevant harmonised standards and common specifications?
- Do Notified Bodies have the capacity to handle what’s ahead?
- Are companies prepared and have the resources in place?”
Again, Tina is looking for ways to share knowledge and support companies through the implementation of the IVDR, starting with the creation of a new training series, this time focusing on the key changes of the In-Vitro Diagnostic Regulation. And as the world is slowly opening up again, with the help of the vaccination roll-out, Tina is optimistic for the future and looks forward to continuing to support clients, provide an optimum service, share her knowledge and grow her team.
Dr Tina Amini
Medical Device Division Director
- Medical devices and their growing regulatory challenges
- New EU In vitro Diagnostics Regulation (IVDR) and Companion Diagnostics
- NDA Webinar: MDR Session 1 an introduction to the key changes in the new EU MDR
- NDA Webinar: MDR Session 2 Quality Management System update to meet MDR requirements
- NDA Webinar: MDR Session 3 Impact of EU MDR 2017/745 on Drug/Device Combination Products (DDCs)
- NDA Webinar: MDR Session 4 Clinical Evaluation of Medical Devices according to MDR
- NDA Webinar: MDR Session 5 Post Market Surveillance (PMS) & Periodic Safety Update Report (PSUR) requirements under the EU MDR
- MDR explained - In collaboration with BioStock