EU ISSUES Q&A DOCUMENT TO PROVIDE FURTHER ANALYSIS OF POTENTIAL NO-DEAL BREXIT

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 
    ECLEVAR 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 ECLEVAR Help?


ECLEVAR 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 azpprovals for device manufacturers. Additionally, ECLEVAR ’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.

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