And so starts the MDR/Brexit fallout… First LRQA and now QS Zurich fall by the wayside
As of June 13th, Lloyds Register Quality Assurance (LRQA) withdrew from MDD and IVDD services (see the announcement here).
It’s official, the first notified body based in UK has pulled out of the race.
Medical Device and IVD Manufacturers currently holding an LRQA CE Mark officially have 90 days to transition their certifications to another notified body. LRQA pointed out that 90 days was more than contractually required (30 days). However, most if not all notified bodies are backlogged on MDD recertifications and MDR applications, not taking any more MDD application, or new clients leaving little room for companies found in this last-minute scramble.
LRQA is well regarded and well established. More retirements will come as the review on MDR recertification process continues.
This past week, QS Zurich, one of the two Swiss based Notified Bodies serving the medical Devices Sector, withdrew its candidacy for MDR designation, citing excessive costs of compliance not justified by a business case.
The combination of (a) Brexit forcing notified bodies to relocate coupled with (b) the stringent new requirements imposed by MDR on notified bodies proved to be too much of a challenge for LRQA and QS Zurich. Things will get worse before they get better as we expect more to follow suit.
So what can be done, and what should companies be doing to prepare?
Contingency and preparedness plans:
Ensure constant communication with your notified body. Ask bold questions and ensure there are well thought out contingency plans. Ask hard questions:
• What happens we if we don’t get MDD recertification on time? (We are seeing significant delays on NB issuing certificates, even after all reviews and audits have been completed.)
• What is the anticipated timeline for MDR designation – when will you be able to start reviewing my MDR files?
• Will we be certified in time for the transition end?
• What are the contingency plans for delays in Notified Body designation?
Ensure proper plans have been solidified for MDD recertification and/or MDR certification.
Perform robust gap assessment and impact analysis on your files. With so many clients and so little time, there are already more than enough challenges. Don’t let deficiencies with your files or data provide a further challenge – or worse still, give the Notified BNod an excuse to reject or put you on the back burner. It’s a cruel fact Notified Bodies will be in a position of being forced to be very strict. Be as squeaky clean as you can.
Are you staying abreast of the new MDR requirements?
• MDR certification will mean a lot more scrutiny on many areas, for example on Clinical Evidence. View our webinar on the subject
• Have you plans for the new documents needed to be part of MDR compliant technical files such as the Summary of Safety and Clinical Performance reports (SSCP) and the Periodic Safety Update Report (PSUR). (See our recent webinar here on why it’s time to be serious about postmarket compliance).
• Are you following the EUDAMED developments? Will you be ready when the time comes – current plans call for all of the industry data to be uploaded within a two-month window.
In midst of this transition, increase resources. Now is the time to bring in additional regulatory and quality resources to navigate these changes and ensure you get over the finish line.
Due to the fact that European regulatory and quality experience is in so much demand, consider other options. Whether it be resources located abroad or consultancies outside of EU who can provide regulatory expertise; companies will be challenged to think outside the box to fill their resource requirements.
Explore new horizons:
Explore international expansions. Where before, Europe was the market of choice for most medical technologies after US FDA registrations or even as the first market, the new MDR rules make a significant shift the balance. In this day in age of international global trade, there are other markets that are welcoming new medical technicalities that may prove fruitful for device and diagnostic manufacturers. Below are some examples:
- Australia now recognizes overseas certifications from the US, Canada and Japan as well as Europe.
- Hong Kong, Taiwan and New Zealand are still booming markets, with relatively straightforward and quick approval pathways.
- Have you evaluated the benefits of MDSAP, which is needed to continue to market in Canada? Here is a webinar on the subject.
The situation in Europe is alarming, but not all hope is lost. Many organizations are successfully navigating this transition and out of the 38 NB MDR Certification Applications, two have already been certified (TUV SUD and BSI (UK)). Let’s keep the eye on the target for MDR: a European market with better quality products that is ultimately better for patients.
However, in terms of the present, now the time to shine for regulatory teams. Ensure you have a comprehensive team or a regulatory consulting partner that can help you navigate this storm.
We can help!
At Brandwood CKC we bring a holistic view to the implementation of new regulations. Our expert team includes years of experience navigating these situations from all fronts: Biocompatibility, IT implementations, Clinical Evidence, Quality Systems, Post Market Surveillance to name a few. Further, we bring knowledge and expertise over all major economies, including the US, Canada, Europe, Australia, Japan and China, to name a few.
Reach out to us and let us help you. Start a conversation and ensure you safely get to your terminal navigating this treacherous road on the least turbulent bandwagon as possible.
Looking to fly south for warmer weather? We have the skills in all aspects of Australian regulatory and reimbursement requirements and can assist you to prepare and file regulatory submissions to TGA. We can also hold Australian licenses on behalf of international manufacturers. Talk to us today about how to leverage international reviews to achieve TGA registration. Contact us for a free, no obligation discussion. Email [email protected] or call us: 1 888-271-5063 (US toll free) ♦ 400-842 7017 (Beijing – toll free) ♦ +61 2 9906 2984 (Sydney)