eu regulations

We all know that the healthcare landscape is undergoing significant transformation. Today’s patients and clinicians are savvy consumers, demanding access to trusted product information to make informed decisions about health care. In parallel, government organisations are supporting patient safety through regulatory mandates around product traceability. To me, one of the biggest changes on the horizon will be new EU requirements for product information. If you are not already preparing for this major new requirement, start now – the clock is ticking. So where are these new data requirements coming from? The new European Medical Device Regulation (EU MDR) will establish a robust, transparent, predictable and sustainable regulatory framework for medical devices to ensure a high level of health and safety whilst supporting innovation by establishing Eudamed, the European UDI database. On May 25 th 2017, the new EU MDR came into force and replaced the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC). One year from now, by May 25 th 2019, you need to have updated your technical documentation and processes to meet the requirements. These changes combined with a complex development process for medical devices make the transition a complicated and time-consuming process. As you will may know, the Regulation affects all medical devices sold in the EU. Different timelines apply to the physical labeling of products, based on risk classification. During a period of 18 months after the date of application of Eudamed, the database must be filled with data on the rest of the devices that are placed on the European market. The go-live date for Eudamed is set on March 26, 2020. On that date Eudamed will be functional for medical devices as well as IVDs. From May 26 th , 2020 for medical devices, and May 26 th , 2022 for...
New EU Regulations on medical devices and in vitro diagnostic medical devices (IVDs) mean all stakeholders, including manufacturers, competent authorities, and Notified Bodies – need new knowledge and skills. The Regulations seek to harmonise requirements, capacities and competencies of Notified Bodies and to me, one of the key advances is the new responsibilities for Notified Bodies. In short, they have a lot more work to do and need to recruit new expertise and upskill existing team members. In 2012, there were 87 Notified Bodies. Since then this number has fallen to 58. Now, they need to be designated under the new Regulations and it has become clear that not all will reapply – and, for those that do, not all applications will be successful. In terms of demand for their services, the only way is up. Additional and stringent requirements mean an enhanced role for Notified Bodies. Some products that were not subject to conformity assessment and post-market surveillance before, notably a large volume of IVDs, will now require much closer scrutiny. There are too few appropriately-staffed Notified Bodies to absorb the workload that is about to land on their desks. For many manufacturers, this will make it challenging to obtain certification under the Regulations. This uncertainty is bad for business, especially smaller players. For patients and health services, it risks delaying or discontinuing access to medical technology products. To address a clear long-term need for new skills, the Lübeck University of Applied Sciences is offering an online MSc in Regulatory Affairs for professionals in the medtech field. While this may not solve the short-term challenges, it can help strengthen the system in the years ahead. To me, this is a really exciting opportunity to bring expertise in regulatory affairs and biomedtech sciences to those who need it. Our faculty...
It is now circa ten months since any well-prepared Notified Bodies (NB) wishing to undertake conformity assessment under MDR (EU) 2017/745 and IVDR (EU) 2017/746 were able to submit formal applications. The date of application of the MDR and IVDR, 27 th May 2020, is currently 20 months away. I would like to publicly acknowledge the significant effort and singular focus of the Competent Authorities (CA) to progress applications and meet the forthcoming deadlines. Given the hiatus before any applications could be formally submitted in November 2017, even the earliest NBs are unlikely to be designated until 2019 – leaving just one year remaining of the original three-year transition period. For BSI, our contact is with our primary CAs the MHRA (UK) and IGJ (NL). Both have been extremely supportive. BSI submitted its applications on day one for both regulations in both jurisdictions. The response from the MHRA was equally rapid and we were fortunate to be the very first NB to undergo MDR JA in early April this year. The MDR/IVDR Commission & Competent Authority Joint Audit (JA) of NB is a crucial process. However, there is concern, regarding the availability of resources given the need to handle all applicant NBs in a timely manner. Recent data published by The European Association for Medical Devices of Notified Bodies (TEAM NB) in July 2018 suggest 11 JAs are currently in the diary (six completed, four scheduled and one with a date to be confirmed). A further five NBs expect to submit this year. So, what are the implications for market access and, more importantly, patient care? Here are what I see as the three primary issues: 1. Many NBs (circa 16) are not ready to apply in 2018. Recent data from the European Commission DG SANTE corroborates Team NBs data...