UK MDR + EU MDR Declaration of Conformity

I'm in the UK and it's a mess ! On the basis that we are selling into the UK and EU countries (and elsewhere) we went for a structured file that complies with 2017/745 so that we would have no issues with our EU Rep, and then we knew that the file would also meet the UK requirements (currently basically 93/42/EEC); the file contains all relevant DoC's but the UK will only be interested in the UK DoC, the EU Rep only with the relevant ones for EU sales (it's a self-declaration anyway but we still prepared our DoC's correctly)

You have to use another UKCA DOC.
The difference to EC DOC is , the title , and also the STANDARDS APPLIED: must be UK standard.
You know UK standard is same as EU standard, but it have difference name now.


Here is a template



MANUFACTURER:
CORITON Instrument Co., Ltd
5F Building C, Gold Power Industry Park,Julongshan Grand industrial Zone, Pingshan Dist.,Shenzhen, China 518118
Tel: +86 755 89581055

MEDICAL DEVICE:
Product:
Model:
GMDN:

CLASSIFICATION - ANNEX IX
Class IIb, Rule 9


CONFORMITY ASSESSMENT ROUTE
Annex II, Item 3 (excluding Annex II.4)


WE, CORITON Instrument Co., Ltd , HEREWITH DECLARE THAT THE STATED
MEDICAL DEVICES MEET THE TRANSPOSITION INTO NATIONAL LAW, THE PROVISIONS OF UK MDR 2002 REGULATION.

STANDARDS APPLIED:
SEE ATTACHED LIST OF STANDARDS FOR WHICH DOCUMENTED EVIDENCE OF COMPLIANCE CAN BE PROVIDED.
ISO 14971: 2012，IEC 60601-1：2015+A1：2012, IEC 60601-1-2:2014, IEC60601-2-4:2010, IEC 60601-1-6:2010, IEC 60601-1-8:2006,
ISO 15223-1:2016, EN 1041: 2008, EN 62304: 2006/AC:2008, EN 62366: 2008


NOTIFIED BODY:
BSI Assurance UK Ltd
389 Chiswick High Road,London,W4 4AL,UK.

IDENTIFICATION NUMBER:


EUROPEAN REPRESENTATIVE:
Umedwings Netherlands B.V.
Treubstraat 1,2288EG,Rijswijk, The Netherlands

UK RESPONSIBLE PERSON:
Umedwings UK LTD
291 Brighton Road, South Croydon,United Kingdom, CR26EQ

PLACE, DATE OF DECLARATION:

SIGNATURE:
NAME:
DATE:
POSITION: MANAGEMENT REPRESENTATIVE



Products List



No
Product Name
Model
GMDN
UMDNS

BasicUDI-DI
1

2

Steve M said:

Hi everyone,

Can you have one declaration in your technical file that declares to conforming to both the EU MDR and the UK MDR? Or do you need two separate declarations?

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As I said in post 5, it is possible to combine both DoC's in one document (EU and UK).
Here's an example found using a quick internet search:
https://www.mascot.no/media/2649/2440-doc.pdf

ChrisM said:

As I said in post 5, it is possible to combine both DoC's in one document (EU and UK).
Here's an example found using a quick internet search:
https://www.mascot.no/media/2649/2440-doc.pdf

Click to expand...

I reviewed this DOC , it did not mention EU REP or UK Rep, it’s ok?

goldenguo said:

I reviewed this DOC , it did not mention EU REP or UK Rep, it’s ok?

Click to expand...

They are a company based in the EU "trading area" (I think technically Norway is outside of the EU but included in the trading arrangements) so they do not need an EU REP. Checking the UKCA regs, currently you need to state on the DoC either the manufacturer's name and address or that of the UKRP..... they have chosen to put their name and address as manufacturers, so, yes their combined/dual-purpose DoC is indeed OK

ChrisM said:

They are a company based in the EU "trading area" (I think technically Norway is outside of the EU but included in the trading arrangements) so they do not need an EU REP. Checking the UKCA regs, currently you need to state on the DoC either the manufacturer's name and address or that of the UKRP..... they have chosen to put their name and address as manufacturers, so, yes their combined/dual-purpose DoC is indeed OK

Click to expand...

Thanks for your explain.

Hello, can I ask how organisation of technical documentation has been accepted by notified/approved bodies? For example we have updated our technical documentation to EU MDR and now want to place the UKCA mark on the product, I understand we need a UK declaration of conformity to UK MDR 2002 but is it ok to point to the same standards used for the EU technical documentation (eg. ISO 14971:2019) as this has not been harmonised by the UK yet? Or do we need two sets of documentation? How has everyone dealt with this? Thank you!

It's best to check and add the UK reference to the Standards where applicable,
e.g. you may declare
ISO14971:2019 on the EU DoC but for the UKCA DoC you should state
BS EN ISO 14971:2019+A11:2021

and yes, it is better (in my experience) to make two separate DoC Documents

ChrisM said:

It's best to check and add the UK reference to the Standards where applicable,
e.g. you may declare
ISO14971:2019 on the EU DoC but for the UKCA DoC you should state
BS EN ISO 14971:2019+A11:2021

and yes, it is better (in my experience) to make two separate DoC Documents

Click to expand...

Thank you for your reply, does this mean you also have two separate risk management reports (for example), one for standard harmonised to UK and one for standard harmonised to EU?

Err...... no. The risks and risk management do not depend on the relevant Standards especially when they are "harmonised".
(OK there may be a slight exception or two, e.g. the risk of one of the Standards being revised and significantly altering what needs to be assessed etc)