The medical regulatory landscape is said to be undergoing its most significant overhaul in years. The new European Union (EU) Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR) have been four years in the making, and are likely to be published in Q1 2017.
We sat down with Theresa Jeary, LRQA Technical Manager, Medical Devices, to get her take on four ways in which the medical device industry will witness a transformation, and how manufacturers can take action to prepare for the changes.
We recognise that with the wide-reaching changes comes a need to stay up-to-date with the latest regulatory intelligence. Our clients, and indeed Notified Bodies like ourselves, both large and small, need to know how the new regulations will impact their organisations over the course of the next three to five years.
Whilst the new MDR and IVDR have not been published as they are still being translated into the 25 EU languages, we already know the form and shape they will take from a regulatory perspective.
1. The new regulations are game changers for manufacturers
The new MDR and IVDR are essentially re-writes on how medical devices and in vitro diagnostic devices (IVDs) are regulated. With new and more detailed requirements comes the need for a lot more investment, particularly to satisfy the increased requirement for clinical information and data.
Manufacturers should naturally expect the CE Marking process to result in higher cost and longer lead-times. With so much at stake, manufacturers really should already start preparing for the new regulations today, and start thinking for the future now.
Talk to your Notified Body in advance about dates before their diaries fill, discuss timescales, and work with them to sketch out an action plan for how you will manage the transition and communicate the requirements to your management team and the rest of your organisation.
2. IVD manufacturers requiring some form of Notified Body involvement skyrocket from 20% to 80%
IVD manufacturers will face a significant impact, so my advice to them would be to pay close attention to the classifications, work on it with the help of a Notified Body, and ramp up their efforts towards meeting the requirements according to a feasible transition timeline.
There are not very many Notified Bodies within the IVD sector, so they should start engaging with one, like LRQA, now.
3. The new regulations have built in more flexibility into the system
The existing Directives, being more than 20 years old now, were absolutely fit-for-purpose at the time, but failed to cover some new ideas and technologies that have developed over time.
The new regulations are allowing for transparency as well as technical advancements currently not foreseen or perceived. The idea is the regulations should not be too rigid or stifling such that it prevents innovation by medical device manufacturers, most of which are small companies with groundbreaking ideas and technology.
4. There is more scrutiny on Notified Bodies and the work that we do
In general, both the new Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR) aim to clarify and strengthen the powers of Notified Bodies.
There will be new organisations, new groups of experts set up to peer review Notified Body work, and that’s a real game changer because it will impact on timelines.
As a result, manufacturers need to consider planning far more in advance to get through the CE Marking process, and understand that timelines shall be longer than currently seen.
About Theresa Jeary
Theresa Jeary has over 25 years’ experience in the medical device and pharmaceutical industries as well as Notified Bodies. She is currently responsible for managing the conformity assessment process and CE Marking decisions for device/drug combination products at LRQA.
A well-known expert within the device and drug product arena, Theresa is a regular speaker at international regulatory conferences and seminars. Over her career, she has conducted successful consultations with many European Competent Authorities, the European Medicines Agency, and the US Food and Drug Administration. Theresa also has extensive Quality Management System expertise, including maintaining ISO 13485 certification and Good Manufacturing Practice for medicinal products.
Theresa holds a Master’s Degree in Pharmaceutical Science from the Royal College of Surgeons, Ireland, and is eligible to be a Pharmaceutical Qualified Person. She is an active member of The Organisation for Professionals in Regulatory Affairs (TOPRA) SPIN Committee for Medtech, and regular contributor to Regulatory Rapporteur magazine.
About the new medical device regulations
Triggered by the Poly Implant Prothèse (PIP) breast implants scandal in 2012, the European Commission proposed new regulations to strengthen the existing Medical Devices Directive (MDD 93/42/EEC) and In Vitro Diagnostic Devices Directive (IVDD 98/79/EC).
The new regulations will introduce several sweeping changes, including tighter and more stringent requirements to ensure patient safety, as well as increased transparency and traceability along the entire supply chain.
With the constantly changing regulatory environment comes a need to stay up-to-date with the latest regulatory intelligence and how the changes impact your organisation.
LRQA’s medical technical experts and industry specialists provide best-in-class medical quality assurance, CE Marking certification, and training services that will equip you with the relevant knowledge at any stage of the product life cycle, towards a timely market launch.
For more information on the new medical device regulations, visit www.lrqa.co.za/medical-devices-service or email firstname.lastname@example.org .