Combination Product Industry News & Guidance
Sharing device-related information and wisdom
that will help you succeed
Brexit Implications & Guidance:
Notified Bodies & the MDR
If wrapping your brain around the new EU Medical Devices Regulation (MDR) wasn’t enough, adding the uncertainty of the UK Brexit plan (or lack thereof) will definitely make your head spin. Many clients and associates of Suttons Creek have asked for our guidance in this complex predicament. In a situation veiled in ambiguity, the best course of action is to gather the facts and make plans that will cover your bases. Suttons Creek has compiled the most current information on how Brexit will affect your combination product business, along with our thoughts on the most strategic, proactive moves to make.
What We Know About Brexit’s Implications for Certification by Notified Bodies:
In the past “Soft Brexit” scenario, a transition plan was proposed. At the March 2018 European Council, the UK and the EU agreed to an “implementation period” that ran past the MDR’s effective date of May 2020, pushing compliance deadlines out for UK companies until December of the same year. During this implementation period, the UK would be treated as a Member State for the purposes of international agreements, including Mutual Recognition Agreements. The UK would continue to respect the decisions reached by the various EU committees regarding the regulation of medicines and medical devices. In turn, this extension would give businesses in the UK and across the EU time to confidently plan for life after the UK withdrawal. This agreement provided cushion and reduced stress, allowing these companies a little extra time to allow the Brexit dust to settle and to implement new processes and systems under the MDR.
Per the original intent in negotiations, UK Notified Bodies would continue to conduct third-party conformity assessments in the UK and the results of these tests would continue to be used and recognized for both the UK and EU markets until that proposed December 2020 implementation period end date. After the implementation period (January 1, 2021 and beyond), whether the process for such products will have to start again in the UK would depend on upon the outcome of even further negotiations on the UK’s future relationship with the EU. As it logically follows that what passed for Notified Bodies and subsequent CE markings would parallel across other business domains, it was reasonable to assume, but not guaranteed, that a similar case would exist for other certified testing services as well.
However, nothing was finalized. And now, we have recently faced a very likely no-deal “Hard Brexit” thanks to Prime Minister Boris Johnson’s “do or die” pledge to exit the European Union by October 31. This date is now past and extended with a vote expected in Parliament by 31 January 2020, three and a half years after the referendum was held. However, this would only mark the next step in the Brexit process. Following its departure, the UK will enter the transition period until 31 December 2020. Therefore, it is uncertain whether we can expect the terms discussed at the March 2018 EC to be enforced. Instead, we are looking at a worst-case scenario that UK certifications would no longer apply in the EU after January 2020. In the best-case scenario, we expect that UK NB certifications will no longer apply after December 2020.
Current Opinion on Preparing for Post-Brexit Certification:
The negotiated “Soft Brexit” case meant that agreements would most likely keep things functioning without impact until December 2020. After the 2020 transition period, assuming that holds, we now face that Notified Bodies based only in the UK will no longer be recognized by the EU.
Based on NSAI and EU posts, “the EU Commission has advised that all EU product suppliers who currently rely on a UK Notified Body for certification of conformity to support their product declaration for ‘CE’ marking purposes, need to obtain an alternative EU Notified Body in preparation for Brexit.” “As from the withdrawal date, UK Notified Bodies will lose their status as EU Notified Bodies and will be removed from the Commission’s information system on notified organizations (NANDO database). As such, UK bodies will not be in a position to perform conformity assessment tasks pursuant to Union product legislation as from the withdrawal date.” From SCI’s assessment, pharma companies working towards Article 117 compliance should do the same.
If your business currently relies on a UK Notified Body, your first step should be to find out whether your UK Notified Body has established itself in an EU 27 member state, as some UK Notified Bodies have relocated to the EU 27 to get ahead of, and remain relevant within, the new EU MDR landscape. If you are lucky and your current Notified Body has been proactive, you may not need to make a change. However, if you find you do need a new EU-accredited Notified Body, you can consult the EU Commission NANDO website.This is a database of all designated bodies which can carry out conformity assessment under EU product legislation – and your best place to find an alternative Notified Body.
The Realities Ahead:
With the compliance rush by companies doing business in the EU market, and with the limited amount of certified EU 27 Notified Bodies available, time is of the essence to get your Notified Body solidified and your project in the pipeline. As of December 2019, there are 55 Notified Bodies certified to the MDD and ONLY SEVEN certified to the MDR. In addition to the reduced number of Notified Bodies certified to the MDR, the requirements for review have increased significantly; you need to prepare for significantly increased review time (and cost)! If you wait too long, you will likely experience limited availability of Notified Bodies, as well as backlogged filings with those that can take on your business. If you haven’t done so already, you are behind the curve and Suttons Creek strongly suggests that you start the process immediately to transfer your files to, and get a new certificate from, an EU 27 Notified Body.
As things continue to progress, we will offer updates on MDR news, Brexit effects and our current recommendations. Email us at [email protected] to set up a call to discuss your specific questions, or to subscribe to our e-newsletter and stay informed.
Steve Badelt, PhD – Steve is a seasoned expert with over 20 years of experience in combination products, engineering management, systems engineering, and business development. He founded consulting firm Suttons Creek, Inc. in 2012, which has served as the device team for pharma on over 50 combination product programs. Steve values helping others learn and grow, and when he is not consulting on behalf of Suttons Creek, he is advising startups, sitting on industry boards, speaking nationally on combination product and connectivity issues and serving as a Graduate Professor at Loyola Marymount University.
Outside sources for this SCI article: