Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

​Hi All,
Does anyone else have a UK NB who either hasn't set up an EU27 entity yet, or who won't be designated in time for a potential hard Brexit?
What steps are you taking?
Thanks

Steps required for hard Brexit are:
setting up a legal entity in EU
setting up an importation site where goods can be recieved
applying for importation license from EU agency
setting up GMP quality system and clear inspection
setting up a testing facility or having a contract with existing contract analytical labs in EU to test and qualify imported products
Hiting or contracting EU QP to release products in EU

above steps are for Pharma Drug products

------------------------------
Rashida Najmi, Sr VP
Quality, Regulatory and Pharmacovigilance
Piramal Enterprises Ltd
Bethlehem PA
USA
------------------------------

Original Message:
Sent: 24-Jan-2019 03:50
From: Anonymous Member
Subject: Brexit - UK Notified Bodies

This message was posted by a user wishing to remain anonymous

​Hi All,
Does anyone else have a UK NB who either hasn't set up an EU27 entity yet, or who won't be designated in time for a potential hard Brexit?
What steps are you taking?
Thanks

This message was posted by a user wishing to remain anonymous

Yes, we have a UK based NB that just this week stated that their associated entities in EU27 would not be in a position to issue certificates by March 29.  In the same message, they also stated that they consider a hard Brexit unlikely, and even if it is the EU27 CAs will not insist on new certificates and AR changes for six months.  Personally, I think this is a head in the sand approach.  We are exploring other NBs, but as everyone know this is an arduous process in the best of times, and with Brexit and the impending MDR, this is definitely not the best of times.  Therefore, I am advising that we try to get as much inventory as possible, 6 months or more, into the EU before March 29 because it won't only be the CAs to be concerned with, but also the Customs people in each country.

Original Message:
Sent: 24-Jan-2019 03:50
From: Anonymous Member
Subject: Brexit - UK Notified Bodies

This message was posted by a user wishing to remain anonymous

​Hi All,
Does anyone else have a UK NB who either hasn't set up an EU27 entity yet, or who won't be designated in time for a potential hard Brexit?
What steps are you taking?
Thanks

Just keep in mind that MHRA issued a statement for pharma and medical devices, i.e. impacting CE Mark of medical devices under Notified Bodies, that these will be recognised until Dec 2020. In the case of a hard or soft Brexit is taken where CE mark is effected at least this gives another potential 19 months to transition to a EU27 Notified Body.  I make these statements with much reservation because no one knows what is going to happen with Brexit but better to plan for the worst hoping for the best.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 25-Jan-2019 06:46
From: Anonymous Member
Subject: Brexit - UK Notified Bodies

This message was posted by a user wishing to remain anonymous

Yes, we have a UK based NB that just this week stated that their associated entities in EU27 would not be in a position to issue certificates by March 29.  In the same message, they also stated that they consider a hard Brexit unlikely, and even if it is the EU27 CAs will not insist on new certificates and AR changes for six months.  Personally, I think this is a head in the sand approach.  We are exploring other NBs, but as everyone know this is an arduous process in the best of times, and with Brexit and the impending MDR, this is definitely not the best of times.  Therefore, I am advising that we try to get as much inventory as possible, 6 months or more, into the EU before March 29 because it won't only be the CAs to be concerned with, but also the Customs people in each country.

Original Message:
Sent: 24-Jan-2019 03:50
From: Anonymous Member
Subject: Brexit - UK Notified Bodies

This message was posted by a user wishing to remain anonymous

​Hi All,
Does anyone else have a UK NB who either hasn't set up an EU27 entity yet, or who won't be designated in time for a potential hard Brexit?
What steps are you taking?
Thanks

Just to clarify regarding Richard's statement:

"Just keep in mind that MHRA issued a statement for pharma and medical devices, i.e. impacting CE Mark of medical devices under Notified Bodies, that these will be recognised until Dec 2020. In the case of a hard or soft Brexit is taken where CE mark is effected at least this gives another potential 19 months to transition to a EU27 Notified Body"

The MHRA issued the following guidance which indicates the possible situation regarding a no-deal Brexit:

"If there's no deal, UK-based NBs will no longer be recognised by the EU after 29 March 2019, meaning the devices they have certified will no longer be in conformity with the applicable EU Directive. As such these products will not be able to be placed on the EU market."

This updated guidance regarding possible no-deal Brexit implies that U.K. will still recognize CE certificates as Richard indicates, but, the other 27 E.U. Member States may not recognize U.K. Notified Body certificates with immediate effect after 29 March 2019. I don't think we have heard anything new from the other 27 EU MS in response to the latest MHRA guidance.

RAPS reported on the latest MHRA guidance in RAPS Regulatory Focus (RF) earlier in January:

MHRA Expands on 'No-Deal' Brexit Preparations for Drugs, Medical Devices

Raps		remove preview
MHRA Expands on 'No-Deal' Brexit Preparations for Drugs, Medical Devices The UK's Medicines and Healthcare products Regulatory Agency (MHRA) issued new guidance on Thursday to propose and further clarify certain regulatory positions in case of a "no-deal" scenario as Brexit looms around the corner. The 14-page guidance document covers the current and possible future regulatory space for medicines and medical devices brought into the UK market, as well as clinical trials conducted in the UK. View this on Raps >

Personally I still cannot believe that a no-deal Brexit will occur, but, I agree with Richard that I cannot predict what will actually occur in just a few weeks. 

------------------------------
Paul Brooks
Executive Director
Rockville MD
United States
------------------------------

Original Message:
Sent: 25-Jan-2019 08:41
From: Richard Vincins
Subject: Brexit - UK Notified Bodies

Just keep in mind that MHRA issued a statement for pharma and medical devices, i.e. impacting CE Mark of medical devices under Notified Bodies, that these will be recognised until Dec 2020. In the case of a hard or soft Brexit is taken where CE mark is effected at least this gives another potential 19 months to transition to a EU27 Notified Body.  I make these statements with much reservation because no one knows what is going to happen with Brexit but better to plan for the worst hoping for the best.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 25-Jan-2019 06:46
From: Anonymous Member
Subject: Brexit - UK Notified Bodies

This message was posted by a user wishing to remain anonymous

Yes, we have a UK based NB that just this week stated that their associated entities in EU27 would not be in a position to issue certificates by March 29.  In the same message, they also stated that they consider a hard Brexit unlikely, and even if it is the EU27 CAs will not insist on new certificates and AR changes for six months.  Personally, I think this is a head in the sand approach.  We are exploring other NBs, but as everyone know this is an arduous process in the best of times, and with Brexit and the impending MDR, this is definitely not the best of times.  Therefore, I am advising that we try to get as much inventory as possible, 6 months or more, into the EU before March 29 because it won't only be the CAs to be concerned with, but also the Customs people in each country.

Original Message:
Sent: 24-Jan-2019 03:50
From: Anonymous Member
Subject: Brexit - UK Notified Bodies

This message was posted by a user wishing to remain anonymous

​Hi All,
Does anyone else have a UK NB who either hasn't set up an EU27 entity yet, or who won't be designated in time for a potential hard Brexit?
What steps are you taking?
Thanks

Paul,

Thank you for the added information to my post ... trying to give some information in limited time.  Absolutely correct that while UK will recognise CE Marked products being brought into the UK until Dec 2020, there is no such counter-part for mainland Europe.  After March 2019, if you are using a UK based Notified Body there is no guarantee that your CE Marked product will be accepted in the other EU27 countries.  Tough situation all around with no clear information yet being made with 2 months to go ...

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 27-Jan-2019 06:46
From: Paul Brooks
Subject: Brexit - UK Notified Bodies

Just to clarify regarding Richard's statement:

"Just keep in mind that MHRA issued a statement for pharma and medical devices, i.e. impacting CE Mark of medical devices under Notified Bodies, that these will be recognised until Dec 2020. In the case of a hard or soft Brexit is taken where CE mark is effected at least this gives another potential 19 months to transition to a EU27 Notified Body"

The MHRA issued the following guidance which indicates the possible situation regarding a no-deal Brexit:

"If there's no deal, UK-based NBs will no longer be recognised by the EU after 29 March 2019, meaning the devices they have certified will no longer be in conformity with the applicable EU Directive. As such these products will not be able to be placed on the EU market."

This updated guidance regarding possible no-deal Brexit implies that U.K. will still recognize CE certificates as Richard indicates, but, the other 27 E.U. Member States may not recognize U.K. Notified Body certificates with immediate effect after 29 March 2019. I don't think we have heard anything new from the other 27 EU MS in response to the latest MHRA guidance.

RAPS reported on the latest MHRA guidance in RAPS Regulatory Focus (RF) earlier in January:

MHRA Expands on 'No-Deal' Brexit Preparations for Drugs, Medical Devices

Raps		remove preview
MHRA Expands on 'No-Deal' Brexit Preparations for Drugs, Medical Devices The UK's Medicines and Healthcare products Regulatory Agency (MHRA) issued new guidance on Thursday to propose and further clarify certain regulatory positions in case of a "no-deal" scenario as Brexit looms around the corner. The 14-page guidance document covers the current and possible future regulatory space for medicines and medical devices brought into the UK market, as well as clinical trials conducted in the UK. View this on Raps >

Personally I still cannot believe that a no-deal Brexit will occur, but, I agree with Richard that I cannot predict what will actually occur in just a few weeks. 

------------------------------
Paul Brooks
Executive Director
Rockville MD
United States

Original Message:
Sent: 25-Jan-2019 08:41
From: Richard Vincins
Subject: Brexit - UK Notified Bodies

Just keep in mind that MHRA issued a statement for pharma and medical devices, i.e. impacting CE Mark of medical devices under Notified Bodies, that these will be recognised until Dec 2020. In the case of a hard or soft Brexit is taken where CE mark is effected at least this gives another potential 19 months to transition to a EU27 Notified Body.  I make these statements with much reservation because no one knows what is going to happen with Brexit but better to plan for the worst hoping for the best.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 25-Jan-2019 06:46
From: Anonymous Member
Subject: Brexit - UK Notified Bodies

This message was posted by a user wishing to remain anonymous

Yes, we have a UK based NB that just this week stated that their associated entities in EU27 would not be in a position to issue certificates by March 29.  In the same message, they also stated that they consider a hard Brexit unlikely, and even if it is the EU27 CAs will not insist on new certificates and AR changes for six months.  Personally, I think this is a head in the sand approach.  We are exploring other NBs, but as everyone know this is an arduous process in the best of times, and with Brexit and the impending MDR, this is definitely not the best of times.  Therefore, I am advising that we try to get as much inventory as possible, 6 months or more, into the EU before March 29 because it won't only be the CAs to be concerned with, but also the Customs people in each country.

Original Message:
Sent: 24-Jan-2019 03:50
From: Anonymous Member
Subject: Brexit - UK Notified Bodies

This message was posted by a user wishing to remain anonymous

​Hi All,
Does anyone else have a UK NB who either hasn't set up an EU27 entity yet, or who won't be designated in time for a potential hard Brexit?
What steps are you taking?
Thanks

Greetings All:
Last week 270 odd pages of Draft Brexit Legislation appeared - basically to enact MDR and IVDR in the UK even though the UK will have left the EU 14 months earlier (or not). There was also a quick appearance of BSI as an MDR-NB on the NANDO website which we suspect was pre-Brexit for UK-legal reasons.
It appears that MHRA will continue to recognize pre-issued certificates: this is the same concept as MDR transition and will mean no or only minor changes and no new products. BUT, I must warn you not to assume all EU-27 CAs will adopt the same attitude. Following the demise of Intertek UK as a NB, interim arrangements that MHRA put in place but these only covered supply in the UK: one of my customers found themselves in very hot water with another CA who took the view your NB is dead, their certificate is worthless and hence their products are fraudulently CE Marked.
It looks like there will be hundreds of pages of rapidly and presumably poorly drafted lagislation to wade through, but as always the devil is in the detail and be sure to read between the lines!

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

Original Message:
Sent: 24-Jan-2019 03:50
From: Anonymous Member
Subject: Brexit - UK Notified Bodies

This message was posted by a user wishing to remain anonymous

​Hi All,
Does anyone else have a UK NB who either hasn't set up an EU27 entity yet, or who won't be designated in time for a potential hard Brexit?
What steps are you taking?
Thanks