New Medical Devices Regulation – “Notified Bodies face a huge workload”
20 March 2019
Blog by Catherinea Jones – Quality Assurance Specialist
On April 5th, 2017, the EU adopted the new Medical Devices Regulation (MDR), replacing the two existing directives: the Medical Devices Directive (MDD) and Active Implantable Medical Devices Directives (AIMD). What does this change mean for the industry? We spoke to Catherinea Jones, who works as a Quality Assurance Specialist. “This is a massive operation.”
Catherinea Jones was involved in the initial GAP assessments to offset existing quality documentation against the new legislation. She also helped create new as well as update quality documentation, for the areas of Post Market Surveillance (PMS), Complaint Handling and Supplier/Distributor Quality Agreements and the Quality Management System (QMS). Furthermore, she was an active member of the implementation of the new MDR.
The goal of the MDR is to get rid of weaknesses in the old directives and to keep up with the rapid changes in the field of medical devices. To do so, a variety of improvements are necessary. Amongst them:
- a stricter ex-ante control for high-risk devices via a new pre-market scrutiny mechanism with the involvement of a pool of experts at EU level;
- the strengthening of post-market surveillance requirements for manufacturers;
- the introduction of an ‘implant card’ containing information about implanted medical devices for a patient;
- improved transparency through the establishment of a comprehensive EU database on medical devices and of a device traceability system based on Unique Device Identification.
Implementation
Companies must have a very clear understanding of the scope and plan of implementation because this is a huge project. There are several assessments which need to be taken into account with implementing the new MDR. Catherinea Jones explains: “The GAP assessment provides a task list for updating your procedures and documentation. This assessment is key to identifying required resources, financial and otherwise, and to setting down timelines.”
A portfolio assessment is necessary to identify the moneymakers as well as the potentially early retirees. On the basis of this assessment, organisations can conclude for which products investments in MDR compliance are justified. A global impact assessment ensures that decisions made are acceptable worldwide and that required changes are identified. A roadmap for master compliance furthers coordination and cooperation between stakeholders, core-teams and dependencies. Finally, regulatory training is imperative to act swiftly and effectively. Catherinea Jones: “Implementation requires not only leaders but also technically competent employees, self reflection and final improvements.”
All the key QMS processes interact. “Working in silos will be detrimental as the interactions between the processes must be understood and agreed upon to ensure harmonisation and appropriate timely reactions and actions”, warns Catherinea Jones.
The MDR will also impact on Post Market Surveillance (PMS). PMS includes all the activities which a manufacturer has to do to assure the security and achievements of his products after he launched them onto the market. The goal of PMS is to have current information about the product’s safety, which makes it possible to improve the product at all times.
Catherinea Jones: “For PMS, the MDR requires manufacturers to be proactive in their efforts to understand field experience. This means that they need to establish new processes to actively seek and review information from a variety of sources. It is specifically stated in part 74 of the explanatory recitals: ‘Manufacturers should play an active role during the post-market phase by systematically and actively gathering information from post-market experience with their devices in order to update their technical documentation and cooperate with the national competent authorities in charge of vigilance and market surveillance activities’. Due to this statement key expectations were established.”
Challenges
Once the MDR rolls into force and the Notified Bodies (NB) are re-designated, they will no longer be able to issue CE marks under the previous directive, even during the transition period. Catherinea Jones explains: “Not only are manufacturers going to have to factor in long periods of time to ensure their NB has the capacity to help them, but they are going to have to implement procedures to deal with unannounced inspections, which are set to take place at least once every five years under the new MDR. Delays in implementation and compliance to the deadline are the main challenges as, due to the MDR Classification rules in Annex VIII, manufacturers must determine whether new conformity assessment routes are now applicable to their product portfolio. If so, they need to get in touch with their NB to take steps to make sure that all requirements are met in the specific time frame.”
A comprehensive plan needs to be put in place to ensure that all legacy products that are placed on the market are compliant with the MDR. All products must be CE marked, including products that are in the development phase. With a high level of technical documentation and detailed requirements for quality management systems, manufacturers will have to ensure that they are continually up to date on the new common specifications. The stricter review and assessment of Clinical evaluations, Vigilance and Post Market Surveillance because of the new MDR will put additional pressure on manufacturers.
Conclusion
Altogether, the new Medical Devices Regulation serves to maintain the safety of medical devices in Europe. Nevertheless, the implementation is going to be a huge project. To do it in the right way, several assessments need to be applied within the organisations such as the GAP assessment, a portfolio assessment and a global impact assessment. Thereby, a roadmap and regulatory training are key in the implementation process. “Furthermore, this change has a real impact on Post Market Surveillance. With big adjustments like this, there are always certain challenges, for example the new workload for NB’s”, concludes Catherinea Jones.
We want to thank Catherinea Jones for her time and sharing her knowledge. Do you also work in the Research & Development sector, and would you like to share your experiences? Let us know and send an email to info@medicaldevicescommunity.com.