Almost two years after its initial publication, many medical device companies are still in the process of adapting to the new EU Medical Device Regulation (MDR). Although this regulation was released in May 2017, the transition process will last through 2020 to take into account the expanded definition of medical devices and more stringent requirements for compliance.
While economic operators under MDR have a lot of reforms to make in order to improve the process of manufacturing medical devices, the Notified Bodies (NBs) responsible for pre- and post-market surveillance must also adjust to new rules. Here’s a brief overview of how Notified Bodies factor into EU legislation, and how the responsibilities and processes of these important authorities are changing under MDR.
What is the mdr?
Replacing Med Device Directive (93/42/EEC), the Active Implantable Medical Device Directive (90/385/EEC) and the In-Vitro Diagnostic Medical Device Directive (98/79/EC), the EU’s Medical Device Regulation (MDR) seeks to improve patient outcomes and healthcare transparency through a variety of standards for companies involved in the manufacturing and distribution of medical devices. While the previous regulations focused on the pre-approval stage of medical device manufacturing, the new MDR focuses more broadly on the life-cycle of medical devices to reduce malfunctioning and improve patient safety.
The new MDR requires that medical device companies implement quality and risk management systems and make information about medical devices accessible to the public through the Eudamed (European Database on Medical Devices) database. MDR also stipulates that medical devices (which include thermometers, wheelchairs, pacemakers, and other medical instruments) are analyzed and marked with a certificate of conformity prior to being released to the market. This “conformity assessment” is where Notified Bodies come into play.
what is a notified body and what does it do?
The European Commission defines a Notified Body as “an organization designated by an EU country to assess the conformity of certain products before being placed on the market.” Notified Bodies are responsible for inspecting a product’s design, manufacturing, and workability to ensure compliance with defined standards and regulations, such as those outlined in MDR. Furthermore, Notified Bodies are empowered to issue an official certification mark or a declaration of conformity, which will permit its sale within the EU. A database of Notified Bodies for all relevant EU legislation is housed under NANDO (New Approach Notified and Designated Organizations). NANDO lists each organization’s identification number and the tasks it is authorized to carry out.
how will notified bodies transition to mdr?
Under the previous regulations, there were 83 Notified Bodies responsible for ensuring compliance of medical devices. However, with the transition to MDR, Notified Bodies must be recertified and adapt to different standards, such as understanding new product codes and adhering to stricter regulations. Since November 2017, organizations have been eligible to apply for re-authorization as Notified Bodies.
In January 2019, the European Union announced that BSI United Kingdom would be the first Notified Body authorized under MDR. Since MDR will apply to newly launched medical devices as well as those currently on the market, Notified Bodies will have a lot of work ahead of them to ensure compliance. In addition, the workload for Notified Bodies is expected to increase as the definition of medical devices expands. With just over a year before MDR takes full effect, medical device companies will want to keep a close eye on the recertification process to understand how the new requirements for Notified Bodies will affect a medical device’s time to market.
want to learn more about mdr?
If your organization is still in the process of transitioning to MDR compliance standards contact a ULG specialist today for help throughout the process. You can also download our ebook What You Need to Know About the EU’s New Medical Device Regulation: MDR & IVDR for an overview of the new legislation and how it applies to your organization.