Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

​​Currently our EC Authorized Representative is located in the UK.  We have made the decision to change to a company located in an EU country.  Has anyone made a change of this nature before and what plan would be acceptable in updating all labeling to reflect the new representative?  Must this be completed before the EU MDR is in effect in March 2020?  Or is a transition plan extending beyond the 3/2020 date acceptable?

Thank you!

At present, there is no deal (including transition period) agreed for Britain to leave the EU, so as such an EUAR based in UK needs to be replaced on 2019-03-29 when Britain will by default leave the EU. If, as seems unlikely, the current "deal" being offered to parliament my the UK government is accepted this would extend to 2020-12-31 with Britain accepting the MDR between 2020-05-26 and 2020-12-31.

We already have one CA questioning distributors about labeling showing an UK manufacturer with no EUAR and an expiration date after March 2019. As a minimum, it would be prudent to have new arrangements in place (labeling and technical files etc) by 2019-03-29 for all products placed on the market after that date.

Be prepared for a busy three months!

Neil

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Neil Armstrong FRAPS
CEO MeddiQuest Limited
Peterborough
United Kingdom
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Original Message:
Sent: 04-Dec-2018 14:57
From: Anonymous Member
Subject: Changing EC Rep from UK to EU rep

This message was posted by a user wishing to remain anonymous

​​Currently our EC Authorized Representative is located in the UK.  We have made the decision to change to a company located in an EU country.  Has anyone made a change of this nature before and what plan would be acceptable in updating all labeling to reflect the new representative?  Must this be completed before the EU MDR is in effect in March 2020?  Or is a transition plan extending beyond the 3/2020 date acceptable?

Thank you!

As mentioned, we have also seen a regulatory authority questioning an AR listing on the labelling post March 2019 for a UK manufacturer.  This would seem to indicate that some have the opinion the UK will no longer be in European Union and maybe not even as part of the EEA or EFTA.  So being like any other country outside the EU, there must be an AR in place within a European country.  And for those manufacturers in the UK MHRA have said that they will recognise MAA and CE Mark until 31 December 2020, but that may or may not include AR representation.  Beginning of a perfect storm !

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 05-Dec-2018 04:47
From: Neil Armstrong
Subject: Changing EC Rep from UK to EU rep

At present, there is no deal (including transition period) agreed for Britain to leave the EU, so as such an EUAR based in UK needs to be replaced on 2019-03-29 when Britain will by default leave the EU. If, as seems unlikely, the current "deal" being offered to parliament my the UK government is accepted this would extend to 2020-12-31 with Britain accepting the MDR between 2020-05-26 and 2020-12-31.

We already have one CA questioning distributors about labeling showing an UK manufacturer with no EUAR and an expiration date after March 2019. As a minimum, it would be prudent to have new arrangements in place (labeling and technical files etc) by 2019-03-29 for all products placed on the market after that date.

Be prepared for a busy three months!

Neil

------------------------------
Neil Armstrong FRAPS
CEO MeddiQuest Limited
Peterborough
United Kingdom

Original Message:
Sent: 04-Dec-2018 14:57
From: Anonymous Member
Subject: Changing EC Rep from UK to EU rep

This message was posted by a user wishing to remain anonymous

​​Currently our EC Authorized Representative is located in the UK.  We have made the decision to change to a company located in an EU country.  Has anyone made a change of this nature before and what plan would be acceptable in updating all labeling to reflect the new representative?  Must this be completed before the EU MDR is in effect in March 2020?  Or is a transition plan extending beyond the 3/2020 date acceptable?

Thank you!

Dear Anonymous,

Since the beginning of the year, MDSS GmbH has been selected by many companies to be the EC REP (Authorized Representative (AR)) in the EU mainland changing from the UK.  Actually, MDSS has already been selected by UK based manufacturers to be their AR in anticipation of a so called hard Brexit. 

The motivation for those companies was to start the labeling process considering their inventory and other aspects.  Feel free to visit our website (www.mdss.com) and you will find under News and Events our "News and Views" containing two articles addressing the Brexit situation.  The deadline is independent of the MDR deadline.  You certainly may call me to discuss these aspects directly.

MDSS guides its clients through the whole process and is most likely the only AR in Europe covering all applicable (!) national registrations and in almost all cases with native speakers for those countries.

------------------------------
Ludger Moeller
President, MDSS GmbH
lmoeller@mdss.com
+49 511 6262 8630
Germany
------------------------------

Original Message:
Sent: 04-Dec-2018 14:57
From: Anonymous Member
Subject: Changing EC Rep from UK to EU rep

This message was posted by a user wishing to remain anonymous

​​Currently our EC Authorized Representative is located in the UK.  We have made the decision to change to a company located in an EU country.  Has anyone made a change of this nature before and what plan would be acceptable in updating all labeling to reflect the new representative?  Must this be completed before the EU MDR is in effect in March 2020?  Or is a transition plan extending beyond the 3/2020 date acceptable?

Thank you!

​If there is a "hard" Brexit, you will no longer have an EC Authorized Representative on March 30, 2019.  This will prevent you from shipping into the EU after that date unless your labeling has been updated.  The expectation is that the UK will be given a transition period until the end of 2020.  If so, then your labeling must be updated by the end of 2020.

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Al Van Houdt RAC
Sr. Mgr. Regulatory Affairs & Compliance
Snoqualmie WA
United States
------------------------------

Original Message:
Sent: 04-Dec-2018 14:57
From: Anonymous Member
Subject: Changing EC Rep from UK to EU rep

This message was posted by a user wishing to remain anonymous

​​Currently our EC Authorized Representative is located in the UK.  We have made the decision to change to a company located in an EU country.  Has anyone made a change of this nature before and what plan would be acceptable in updating all labeling to reflect the new representative?  Must this be completed before the EU MDR is in effect in March 2020?  Or is a transition plan extending beyond the 3/2020 date acceptable?

Thank you!

Hello Anon -

We are in the same boat. But, we chose a non-UK based EUAR couple months ago and just signed a contract with them. We are transitioning to the new EUAR effective March 30th because UK is expected to leave the EU on March 30, 2019, 00:00 UK time as others had mentioned. Is the Brexit date for <g class="gr_ gr_488 gr-alert gr_gramm gr_inline_cards gr_run_anim Grammar only-ins replaceWithoutSep" id="488" data-gr-id="488">UK</g> confirmed? No one really knows yet. Below is the statement from the notice published by the European Commission to their stakeholders on Jan 22, 2018. 

"Authorised representatives or responsible persons established in the United Kingdom will not, as from the withdrawal date, be <g class="gr_ gr_1595 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling multiReplace" id="1595" data-gr-id="1595">recognised</g> as <g class="gr_ gr_19 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling multiReplace" id="19" data-gr-id="19">authorised</g> representatives or responsible persons for the purposes of the applicable Union product legislation. Therefore, manufacturers are advised to take the necessary steps to ensure that, as from the withdrawal date, their designated <g class="gr_ gr_20 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling multiReplace" id="20" data-gr-id="20">authorised</g> representatives or responsible persons are established in the EU-27."

I strongly recommend you to make plans assuming March 29th, 2019 as your due date for this transition. We have a plan of action in place which has been communicated to our notified body. We have sorted out documentation identifying the EU rep information. These documents include labels, IFUs, marketing brochures and other operating guides etc., For the product that is currently in the filed (labeled with existing EU rep infm'n), we asked our existing <g class="gr_ gr_2839 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling ins-del multiReplace" id="2839" data-gr-id="2839">EUAR</g> to direct any customer queries and complaints to the new EUAR starting March 30, 2019. 











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Phani Puppala
Franklin MA
United States
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Original Message:
Sent: 04-Dec-2018 14:57
From: Anonymous Member
Subject: Changing EC Rep from UK to EU rep

This message was posted by a user wishing to remain anonymous

​​Currently our EC Authorized Representative is located in the UK.  We have made the decision to change to a company located in an EU country.  Has anyone made a change of this nature before and what plan would be acceptable in updating all labeling to reflect the new representative?  Must this be completed before the EU MDR is in effect in March 2020?  Or is a transition plan extending beyond the 3/2020 date acceptable?

Thank you!