Brexit Transition Arrangements & Import into the EU

twanmul

Involved In Discussions
#1
Hi all,

I have a long question regarding the end of the Brexit Transition arrangements and what happens regarding import into the EU from the end of the year.
My company manufactures IVD devices in the UK and currently has distribution agreements for distribution into the EU. Let's say we have the following set-up:

Manufacturer - UK Based - Registered with the MHRA and sells to UK customers, using distributors for elsewhere
Distributor A - Sweden Based - Distributes to Swedish and Danish customers
Distributor B - Netherlands Based - Distributes to Dutch customers only

From the end of the Brexit transitional period (currently 31st December 2020), we will require an EU ARP which we've put in place. My interpretation of the set-up then becomes:

Manufacturer - UK Based - Registered with the MHRA and sells to UK customers
EU ARP - Germany Based - Registers devices with the local Competent Authority
Distributor (and Importer) A - Sweden Based - Imports and Distributes to Swedish and Danish customers
Distributor (and Importer) B - Netherlands Based - Imports and Distributes to Dutch customers (i.e. based in Netherlands) only

My assumptions with this are that: i. we will be able to have parallel import (I assume it would be on the say-so of the German based Competent Authority?); ii. we will need to amend our distribution agreements to include importation into the EU and have the current distributor ; iii. if neither Distributor A nor B were willing to be an importer, we could utilise a third party that would act as an importer (possibly needing to re-arrange the distributor agreements appropriately to fit), iv. if we don't make the contractual amendments that we will not be able to have an importer into the EU.

Are my assumptions correct and if not, what have I incorrectly assumed or not considered? Hopefully somebody can help!
Thanks
 
Elsmar Forum Sponsor

twanmul

Involved In Discussions
#3
Don't forget that NI and GB will regulate differently. :(
Yes, I'm aware of this problem but thank you for pointing this out. We have distributors in NI that send to customers in NI and ROI too (though didn't include this in my problem above as it would have muddied the waters even more), which makes things particularly difficult!
 

Philip B

Involved In Discussions
#4
We are in a similar situation. We don't want any of our EU distributors to be the importer (don't want their name on labelling) so we are looking for an importer. We are setting up a registered office in Germany and I'm hoping that this can be our importer. I know that the rules have tightened considerably for who can be an AR but the regs are more vague regarding importers. I am assuming that transactions will need to be via the importer, to show that they placed the goods on the market.
 
Thread starter Similar threads Forum Replies Date
dinaroxentool Selling a product in Both UK and EU after Brexit UK Medical Device Regulations 9
dgrainger Informational MHRA - Regulating medical devices in the UK - Post Brexit - 2021-02 UK Medical Device Regulations 0
E Brexit UK MDR brexit out of sync with EU MDR deadline? UK Medical Device Regulations 4
M Status of Medical Device Regulations in UK Post-Brexit Other Medical Device Regulations World-Wide 10
M Informational Update from GOV.UK – Regulating medical devices in the event of a no-deal Brexit – UK Responsible Person Medical Device and FDA Regulations and Standards News 0
M Informational HPRA Brexit Preparedness Checklist Medical Device and FDA Regulations and Standards News 2
M Informational From RAPS – Prep for Brexit: UK Seeks £25M Freight Service to Deliver Medicines, Devices Medical Device and FDA Regulations and Standards News 0
DMLqms Exporting into the EU from UK after Brexit EU Medical Device Regulations 3
M Informational TGA – Brexit – Implications for therapeutic goods in Australia Medical Device and FDA Regulations and Standards News 0
JoshuaFroud CE Marking and Brexit - Product shipped to a distributor prior to the March deadline EU Medical Device Regulations 2
M CE mark validity after Brexit, 29th March '19 EU Medical Device Regulations 6
M Informational Design for new product safety marking for the no-deal Brexit scenario Medical Device and FDA Regulations and Standards News 1
M Informational UK – Brexit operational readiness guidance for the health and care system in England Medical Device and FDA Regulations and Standards News 3
M Pharmaceuticals News UK – Further guidance note on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal Medical Device and FDA Regulations and Standards News 0
M Medical Device News Letter to the health and care sector: update on preparations for a potential no-deal Brexit Medical Device and FDA Regulations and Standards News 0
M Medical Device News Brexit - Withdrawal Agreement and Political Declaration laid before Parliament following political agreement. EU Medical Device Regulations 4
S How to Define Importers under EU MDR / Brexit EU Medical Device Regulations 3
F BREXIT - What/How are You and Your Business Preparing for It? EU Medical Device Regulations 20
R Brexit - European Commission - The impact of the Brexit per March 29, 2019 EU Medical Device Regulations 3
S Transition training for Internal Auditor from ISO 9001: 2008 to the ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M MD Class I transition period MDD to MDR - changes? EU Medical Device Regulations 1
Q Transition from QC Inspector to QA Engineer Career and Occupation Discussions 4
Y MDR Transition - make "Available on the market" after CE certificate expiration EU Medical Device Regulations 3
shimonv MDR transition checklist EU Medical Device Regulations 0
T Transition from ISO9001 to AS9100D: O&G to Aerospace AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
J MDD to MDR transition - Time required for the implementation of the MDR EU Medical Device Regulations 7
S MDR consultants - in search of recommendations for a consultant for MDR transition. Paid Consulting, Training and Services 7
K Annex XVI Device Transition Timeline under the MDR EU Medical Device Regulations 2
B ISO 9001:2015 Transition: Much Easier Than You Think! Misc. Quality Assurance and Business Systems Related Topics 0
M UDI transition period and implementation EU Medical Device Regulations 6
M Informational The US FDA is Recommending Transition to Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication Medical Device and FDA Regulations and Standards News 0
O New MDR 2017/745 Transition Strategy - 2019 Manufacturing and Related Processes 3
A How to manage the QMS system and SOP during the transition from MDD to MDR EU Medical Device Regulations 9
S When is the last date for transition to ISO/IEC 80079-34:2018? Other ISO and International Standards and European Regulations 0
K CE mark transition and new regulations CE Marking (Conformité Européene) / CB Scheme 0
Ronen E Informational ISO 13485:2016 Transition Period End - 1 March 2019 ISO 13485:2016 - Medical Device Quality Management Systems 0
T MDR Guidance Book - Useful for MDR transition? EU Medical Device Regulations 1
M Medical Device News EU – Transition Timelines from the Directives to the Regulations – Medical Devices and in vitro Diagnostic Medical Devices Medical Device and FDA Regulations and Standards News 13
H Transition to ISO 13485:2016 together with ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 12
Ed Panek Transition to IEC 60601 4th Edition - Risk Analysis and test submissions CE Marking (Conformité Européene) / CB Scheme 2
M Medical Device News Health Canada - Medical Device Single Audit Program (MDSAP) Transition Plan Canada Medical Device Regulations 2
M Medical Device News FDA News - 26-09-18 - FDA Reveals Vision for the Transition to ISO 13485 Other US Medical Device Regulations 1
M MDSAP Transition - Health Canada Website Notice on Apr 13 2018 Canada Medical Device Regulations 1
O IEC 60601-1-2 4th edition transition deadline Dec 31 2018 CE Marking (Conformité Européene) / CB Scheme 1
qualprod Transition and recertification at the same time? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
P How To Transition From AS9100c to AS9100 Rev. D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
A ISO 14001:2015 transition from the 2004 standard ISO 14001:2015 Specific Discussions 8
F IATF 16949:2016 transition audit - Internal Audit Closures IATF 16949 - Automotive Quality Systems Standard 13
W AS9120A to AS9120B transition AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
L Transition date to IEC 60601-1-11:2015 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1

Similar threads

Top Bottom