Mandatory Documents for EU authorized Representative under MDR

Kuldeep Singh

Involved In Discussions
#1
Hi Everyone,

As we are moving to new MDR . Please guides us about the type of documents for a class IIb product we have to disclose with our European Authorized Representative (EAR). Are there any new additional documents which we have to share with him due to new Norms or Regulations (i.e. MDR other than MDD)?
Documents like IFU, Labeling, Technical specs, DOC, EHSR, Test Reports, change management (ECNs related to European Market), Product & System Certificates etc. would be sufficient or we have to provide him all the design documents like circuit Diagram, Software document, source code, Bill of Material etc.

For a manufacture , it is mandatory to share all the confidential data due to regulatory requirements?
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Article 11

Authorised representative

1. Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative.

2. The designation shall constitute the authorised representative's mandate, it shall be valid only when accepted in writing by the authorised representative and shall be effective at least for all devices of the same generic device group.

3. The authorised representative shall perform the tasks specified in the mandate agreed between it and the manufacturer. The authorised representative shall provide a copy of the mandate to the competent authority, upon request. The mandate shall require, and the manufacturer shall enable, the authorised representative to perform at least the following tasks in relation to the devices that it covers:

(a) verify that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;

(b) keep available a copy of the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, issued in accordance with Article 56, at the disposal of competent authorities for the period referred to in Article 10(8);

(c) comply with the registration obligations laid down in Article 31 and verify that the manufacturer has complied with the registration obligations laid down in Articles 27 and 29;

(d) in response to a request from a competent authority, provide that competent authority with all the information and documentation necessary to demonstrate the conformity of a device, in an official Union language determined by the Member State concerned;

(e) forward to the manufacturer any request by a competent authority of the Member State in which the authorised representative has its registered place of business for samples, or access to a device and verify that the competent authority receives the samples or is given access to the device;

(f) cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices;

(g) immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated;

(h) terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation.

4. The mandate referred to in paragraph 3 of this Article shall not delegate the manufacturer's obligations laid down in Article 10(1), (2), (3), (4), (6), (7), (9), (10), (11) and (12).

5. Without prejudice to paragraph 4 of this Article, where the manufacturer is not established in a Member State and has not complied with the obligations laid down in Article 10, the authorised representative shall be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer.

6. An authorised representative who terminates its mandate on the ground referred to in point (h) of paragraph 3 shall immediately inform the competent authority of the Member State in which it is established and, where applicable, the notified body that was involved in the conformity assessment for the device of the termination of the mandate and the reasons therefor.

7. Any reference in this Regulation to the competent authority of the Member State in which the manufacturer has its registered place of business shall be understood as a reference to the competent authority of the Member State in which the authorised representative, designated by a manufacturer referred to in paragraph 1, has its registered place of business.
 

Kuldeep Singh

Involved In Discussions
#3
Thanks for reply

We already read this and the words "copy of technical documentation" is our main confusion. Our Technical construction file (TCF) contain Circuit diagram /Bill of material .

So, Is it right to share all the details (as included in Technical Documentation ) by keeping in mind about manufacture's confidentiality ?
 

Ronen E

Problem Solver
Staff member
Moderator
#4
The requirements for the Technical Documentation are detailed in Annexes II & III (and there's also a guidance paper from BSI).

Whatever you concluded should be included in your Technical Documentation should be copied and handed to the AR. If you're concerned with confidentiality and can't avoid inclusion in the TD, maybe consider an escrow arrangement (safekeeping by a 3rd party legally tied by confidentiality, e.g. a lawyer in the AR's member state).
 

fialor

Involved In Discussions
#5
Where there is a business reluctance to share the technical file content (almost all the time), my understanding is that an agreement that allows the AR access to the Technical File for when he/she receives a request may be sufficient.
It is worth enquiring from your NB if this approach (or any other approach that you are considering) is worth doing.


The requirements for the Technical Documentation are detailed in Annexes II & III (and there's also a guidance paper from BSI).

Whatever you concluded should be included in your Technical Documentation should be copied and handed to the AR. If you're concerned with confidentiality and can't avoid inclusion in the TD, maybe consider an escrow arrangement (safekeeping by a 3rd party legally tied by confidentiality, e.g. a lawyer in the AR's member state).
 

WAQAR-QMS

Starting to get Involved
#6
Good Day everyone,
Is there some registration requirements for being and EU Rep. ?
Or simple neutral person (residing in EU) can be nominated as EU Rep ?

If there is some registration requirement, it would great if point me in direction.
 

Ronen E

Problem Solver
Staff member
Moderator
#7
@fialor
A manufacturer with a registered place of business outside the Union shall, in order to allow its authorised representative to fulfil the tasks mentioned in Article 11(3), ensure that the authorised representative has the necessary documentation permanently available.
I struggle to see how anything but a full copy residing with the AR at all times will meet this requirement, but if the auditing NB is happy with other arrangements that probably all that matters.
 

Ronen E

Problem Solver
Staff member
Moderator
#8
Good Day everyone,
Is there some registration requirements for being and EU Rep. ?
Or simple neutral person (residing in EU) can be nominated as EU Rep ?

If there is some registration requirement, it would great if point me in direction.
Everything you need to know about "EU Rep" (Authorised Representative) is in post #2 above.
 

WAQAR-QMS

Starting to get Involved
#9
Thanks Ronen for referring.
I had read all responsibilities of AR, though I wonder two questions that are not clear about AR:
1. Is it mandatory for AR to have registered business address ?
2. Any qualification or registration requirements for AR as an individual ?
 
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