Twelve (12) months ago, the EU Commission published a Notice to Stakeholders, “Withdrawal of the United Kingdom and EU Rules in the Field of Industrial Products,” that described the consequences of the withdrawal of the UK from the EU as of 29 March 2019. This document explains the impact on Economic Operators and Notified Bodies, emphasising that UK Notified Bodies would no longer be in a position to perform conformity assessment tasks—thus, certificates issued by Notified Bodies designated by the UK Competent Authority would no longer be valid. Similarly, the Notice to Stakeholders also clarifies that “Authorized Representatives” in the UK would not have the ability to perform conformity assessment tasks post-Brexit.
While the UK still remains part of the EU (EU-28) until 29 March 2019, following this date, the UK will become a “3rd country,” and the Union will become known as EU-27.
The EU Commission has now issued an accompanying “Questions and Answers” document which gives helpful examples of various scenarios for manufacturers when placing devices on the market, in addition to collateral requirements.
This information is only relevant should the UK leave without a ratified withdrawal agreement (No-Deal Brexit), which would also mean the absence of a transition period.
The document details:
- Examples of requirements for goods placed on the European Union market (EU-27) before the withdrawal date
- Responsible persons and their need to be established in the EU-27 after the withdrawal date (with goods labelled accordingly)
- Importation of goods for the UK to the EU-27, and the change of role of EU-28 distributors to an EU -27 importer
- Transfer of Notified Body certificates to EU-27 Notified Bodies, and the need for this to occur prior to 29 March 2019:
- Declarations of conformity will require updating to reflect any new Notified Body (as well as the old UK Notified Body)
- For devices not yet manufactured or placed on the EU-27 market, new Notified Body numbers will be required
- There appears to be no allowance for a pragmatic transfer of labelling approach as described in the Notified Bodies Operation Group (NBOG) best practice guidance 2006-1, which suggests the labelling transition period should not exceed six (6) months unless duly justified, when transferring to another Notified Body
- Accreditation certificates issued by the UK Accreditation Service (UKAS) will be no longer valid after 29 March 2019
The above mentioned documents may be found by clicking here.
Additionally, the above guidance also references the “Blue Guide” document which further details to the implementation of EU product rules (available here). Chapter 2 of the Blue Guide discusses the critical concepts when “making available on the market” and “placing on the market” devices in the EU.
Another useful reference is the “Informative Document of the Commission’s Services on Placing on the Market of Medical Devices” dated 16 November 2010, found here.
Next Steps
NAMSA recommends that all medical device manufacturers review this information to assist in planning for Brexit, however, it is important to remember that the above circumstances will only be realized in the event of a No-Deal Brexit.
Although this scenario remains a possibility as the UK government continues to insist on the viability of this scenario, the potentially catastrophic nature of such an outcome appears to be understood on both sides of the English Channel.
Furthermore, in the unlikely event that such a situation occurs, it is estimated that approximately 40 percent of all EU Medical Device Directive (MDD) certificates are issued by UK Notified Bodies, with a substantial proportion assigned to high-risk devices.
It would seem unlikely that the EU-27 would wilfully implement a decision that would remove these devices immediately from the EU-27, as there would be a subsequent impact on patients, increasing the likelihood that the UK would take a pragmatic approach. These devices obviously did not become unsafe overnight, and it is hoped—and expected—that practical solutions to avoid the damaging impact on patients in both the UK and EU-27 will be implemented, either at a national or EU Commission level.
How Can NAMSA Help?
NAMSA is the industry leader in driving successful regulatory outcomes through effective interactions with the EU Commission and Notified Bodies. Our internal teams of medical device development experts communicate with EU entities nearly every day and are the most experienced in industry at accelerating regulatory submissions and approvals for device manufacturers. Additionally, NAMSA’s Regulatory Team is enriched with multiple experts from five leading Notified Bodies that have a deep-rooted understanding of EU submissions, proven to save medical device organizations up to $17M in costs and 23 months in development timelines.
If you would like to discuss the impact of these recent EU regulatory changes, please get in touch with us by visiting https://www.namsa.com/contact-us/ or by calling us directly at +1-419-666-9455.
Adrian Keene
Adrian is Director of EMEA Consulting Services at NAMSA where he utilizes his broad experience of changing EU medical device regulatory requirements to support clients worldwide. He is responsible for new product development using EU regulatory requirements to provide a balanced interpretation of the needs and expectations of both competent authorities and manufacturers. He works with a broad range of devices including drug-device combination products. Adrian previously Head of Notified Body of SGS in the UK, and also served as the Global Clinical Affairs and Regulatory Manager for Medical Devices (SGS) with responsibility for conformity assessment activities of high-risk (Class III) devices under the Medical Devices Directive (MDD). In all, Adrian has 25 years’ experience in the medical device industry. He attended the School of Pharmacy at the University of London following and conducted postgraduate research in “Retinoid-Induced Skeletal Toxicity.” He also holds a diploma in “Managing Medical Product Innovation” from the Scandinavian International Management Institute.