Supporting development through medical device directive changes
Created in 2012, Scandinavian Development Services is a Swedish consultancy providing regulatory, scientific and biostatistical support for companies developing drugs and devices.
In May this year, new regulations on medical devices came into force in the European Union. These have been designed to replace the existing directives and modernise the existing system. The changes include stricter controls for all devices, stronger rules for post-market surveillance and better reinforcement of the need for clinical evidence; and more co-ordination transparency across Europe.
"What was previously the three directives that made up the medical device legislations [MDD, AIMDD, and IVDD], has been moved into two new regulations, the Medical Device Regulations [MDR] and In Vitro Diagnostic Regulations [IVDR]," explained Stina Johansen, director, Medical Devices, Scandinavian Development Services. "As these now have been published in the Official Journal of the European Union, we will move into a three year transition period for MDR before the 'Date of Application' on May 26th 2020. During this time, certification under both MDD and MDR are possible, but after spring 2020, all medical devices have to be certified under the new regulation."
The transitional timelines are multiple and complex, for example, certificates under the current MDD or AIMDD will remain valid as stated on each certificate (but no longer than May 26th, 2024), but the requirements on post-market activities in the MDR will apply from May 2020.
The challenges of the new regulations
While these new regulations will be a challenge for companies because of the substantial increase in requirements, they will improve transparency and traceability, and will increase the need for examinations by a third party (Notified Body) with the intention to ensure that devices are safer.
"There has long been a misperception that the requirements are lower for the regulation and marketing of medical devices. While this is true for low-risk devices – it is reasonable to have lower expectations for a plaster compared with a pacemaker – the higher-risk devices have always needed risk-benefit analyses and the provision of technical, biological, and clinical data. Without doubt, the expectations have increased for devices in all of the risk-classes," said Johansen. "One of the areas where there will be an increase in expectations is the clinical evaluation, clinical data and post-market clinical follow-up. This will take time to implement and complete, and companies will need to create a strategic plan to prepare for meeting the surveillance requirements by May 2020 as well as for certification under MDR."
In the past, many products have based their clinical evaluations on equivalent products. The regulations, however, will require the manufacturers to clearly demonstrate that they have sufficient level of access to the technical, biological and clinical characteristics to back up any claims of equivalence.
"Some companies have previously based their clinical evaluations on competitor products that are already on the market, and haven't had to include much data to justify equivalence. These new requirements for supporting data will need agreements with other companies to share information to have sufficient access to the data, or to create your own clinical data," said Johansen.
Products that have already been certified will need to transition to a certificate under MDR once the certificate expires. Because the classification rules have changed, some products may need to meet the requirements of a higher class, and therefore will need more data. For these the transition period will provide a breathing space in which to collect, or create, the new data that is required. Even for those products that haven't been reclassified, there will be additional requirements that need to be met.
Meeting the challenge with Scandinavian Development Services
One of the key requirements needed by the new requirements is more data supporting the clinical evaluation, and a more continuous process for gathering that data. This will include follow up on patients in clinical trials, and real world data from products on the market, and is one of the areas where Scandinavian development Services can help.
"We can support companies through their product development, helping them to comply with the new regulations by identifying gaps in their documentation and data and designing the investigations that they need. This is based on our in-depth knowledge in regulatory affairs, and our experience in implementing processes in organisations," said Johansen. "We can also support by helping to update or create quality management systems to meet the new requirements."