By Angela Stokes
New regulations, which were signed off in June 2016, will affect all device manufacturers looking to sell products in the EU, with stricter requirements being introduced in order for these products to be approved. Here, we provide some essential information about the new Medical and In-vitro Device Regulations, and what it means for those of you involved in medical devices development.
On 2016年6月27日, the final drafts of the Medical Device Regulations (MDR) and In-vitro Medical Device Regulations (IVDR) were made public and they are expected to be adopted and enter into force in Q1 of 2017. [1]
The transition period will be three years for the MDR and five years for the IVDR, meaning that the dates of application (DOA) will be Q1 2020 and Q1 2022, respectively.
So … We have three (or five) years to prepare for this; we don’t have to do anything immediately, right? Wrong! There are some pretty major changes, so it is essential that medical device manufacturers get management engaged in the process now so that money and resources can be available to support and implement the new device regulations.
Redesignation of Notified Bodies
Under the regulations, all Notified Bodies (NBs) will need to be redesignated. The NBs can start to apply for this redesignation in July/August 2017 – six months into the transition period. It could take 12-24 months for the redesignation evaluation, as it is a new process and more bodies are involved in assessing, so there is potential for MDR certificates not to be available from the redesignated NBs until as late as Q1 2019.
There is also an issue regarding the availability of NBs. There will be fewer NBs and many are already drowning under the extra work required from the “unannounced audits” program. The number of NBs is falling and the expertise is being switched to other CE Marking projects (Conformité Européenne or European conformity). This is already causing delays in reviews and certifications. It is essential that diagnostic medical devices manufacturers establish a good relationship with their NB now to ensure that they are not “forgotten” to reduce the possibility of their products being pushed to the back of the evaluation queue – this is especially important for devices companies with only one or two products.
We should also not be surprised to see NBs push up their costs for devices approval certification, as the extra work involved in the assessment will need to be recouped.
So, if the approval process takes longer and there is a potential for a higher cost, medical devices companies need to start looking at their cash flows now as product release may be delayed, which, in turn, could cause some loss of faith from customers requiring the approved medical devices.
Want more advice on how the Medical Devices Regulation affects you?
At Syneos Health™, we can provide medical devices regulatory consulting services to help you get your product approved. We have a dedicated business group focusing solely in this area so you can benefit from their knowledge to guide you from concept to marketing.
We’ll be posting new blogs from across our Business Units and therapy areas regularly, so be sure to check back soon for more industry insights from our experts.
[1] https://www.meddeviceonline.com/doc/eu-finalizes-revamped-medical-device-ivd-regulations-0001
About the Author
Angela Stokes is Senior Director, Regulatory Consulting, regionally based in the U.K. Her duties include providing a general regulatory consultancy for customers, preparing and reviewing regulatory submissions, development of the regulatory team, and participating in and leading business development initiatives. Angela was recently elected as the future President of The Organization for Professionals in Regulatory Affairs (TOPRA). TOPRA is the professional membership organization for individuals working in healthcare regulatory affairs.
