Submission of MDR File - Partner Companies - Computed Tomography (CT)

[Kuldeep Singh]

Hi Everyone ,

Hope you and your family are good,

We are introducing ourself as Manufacturer of Medical Devices which falls under Class IIb , Annex VIII Rule 10, of EU 2017/745.

We are planning for submission for one of our product which is Computed Tomography (CT) , a 32 Slice machine as per Medical Device Regulation (EU) 2017/745. This equipment is jointly developed by a Multinational Company (MNC) and our company.

All of the major components such as X-Ray tube, Flat panel detectors, Firmware , software and all other electronic assemblies, are brought out by our partner i.e MNC . It is noted that, They (MNC) have already CE certified CT machine which were using the same components with same manufacturing processes which they provide to us.

Now we want to understand regarding
1. Documentation required from our partner so that we can apply for the CE certification of CT Machine .
2. In case of Software / Firmware , what should we take from our partner to comply with IEC 62304 and what should we include in Software verification and Validation Report in order to comply with Design verification.
3. Can anyone guide me for UDI implementation , SRN and working status of EUDAMED.

 

[monoj mon]

1. Documentation required from our partner so that we can apply for the CE certification of CT Machine .

You should get everything that the Technical documentation requires under MDR 2017/745.

3. Can anyone guide me for UDI implementation , SRN and working status of EUDAMED.

What kind guidance you need! I think SRN shall be given during the time of registration and EUDAMED is not expected to be launched anytime soon, at least not this or next year as it was delayed by two years.

 

[Kuldeep Singh]

Thanks for your response

We request our partners for Technical documentation related to Design (Such as Design Input , design verification for brought out items), but they are unable to provide us in order to maintain their confidentiality .

Apart from this , for Software documentation, they only provide us the IEC 62304 test report but cant provide us related documents such as Software Development Plan, Software Requirement Specification software architecture etc.

In the absence of these documents , how can we comply with EU MDR.

 

[monoj mon]

We request our partners for Technical documentation related to Design (Such as Design Input , design verification for brought out items), but they are unable to provide us in order to maintain their confidentiality .

In the absence of these documents , how can we comply with EU MDR.

Well, negotiate with them to find out a solution. One way-out could be, you prepare a high-level document for the contents of the Technical Documentation (may be in a tabular format) and refer to the relevant "document name/number" that you have included in the "Technical Documentation". For all those documents from your partner company refer to their "internal document name/number" with a NOTE for the reviewer that "those documents are not included currently due to confidentiality and the partner company will provide it to the reviewer directly upon request". And then discuss this way-out with your partner company if they agree with it or not. Prior to asking for review, consult with your notified body regarding this provision and ask for their opinion whether or not it will satisfy their requirements!

Although you are jointly developing the device with that MNC, you shall have your own documented design input-output requirements for the intended use of the device! You can't simply get parts of the device randomly from someone! Right! If so, then the other option will be to use those documents for your Technical Documentation and for all those "engineering proprietary details" of the parts from the MNC refer to their "internal documentation name/number" and then follow what I have said above.

 

[Kuldeep Singh]

Thanks Monoj Mon , As per your guidance , we will work on it and discuss with NB as well as our partner

 

[monoj mon]

No problem, regarding the UDI implementation I wrote two articles. But those two don't cover everything, you will need to follow the MDR 2017/745 document as well as other available online blogs anyway. If you are interested then I can share with you, but those are in LinkedIn as I don't have any blog or website.

 

[dgrainger]

You (and AR) are required to have all documentation 'available' for the competent authorities to see upon their request.

Article 10.8:

8. Manufacturers shall keep the technical documentation, the EU declaration of conformity and, if applicable, a copy​

of any relevant certificate, including any amendments and supplements, issued in accordance with Article 56, available​

for the competent authorities for a period of at least 10 years after the last device covered by the EU declaration of​

conformity has been placed on the market. In the case of implantable devices, the period shall be at least 15 years after​

the last device has been placed on the market.​

Upon request by a competent authority, the manufacturer shall, as indicated therein, provide that technical documentation​

in its entirety or a summary thereof.​

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.​

 

[Kuldeep Singh]

Can anyone suggest me about the documentation related to Annex III ( Technical Documentation on Post Market Surveillance) .

As our product (CT Scan Machine ) is newly developed machine and having no previous generation of the device produced by us.

In that case what are the documents we need to submit to NB such as PSUR report, PMS plan , PMCF plan etc.?

 

[monoj mon]

You may include a PMS Plan which mentions your procedure to prepare the PSUR (or include a template of it). See the below images (captured from the BSI Guidance on MDR documentation), might be helpful for you. As your device is new, you may ignore the point 6.7.1

 

[Kuldeep Singh]

Hello Everyone!!

Can anyone help me out for resolving the query about applicability of Machine directory (2006/42/EC) as we are manufacturer of Medical devices (such CT Scan, C-Arm machine etc) and MDD (93/42/EEC) &/or MDR EU 2017/745 applicable on us. In that case what should we do?

Show the compliance with both the directives i.e MDR EU 2017/745 as well as 2006/42/EC?

Can anyone explain the term define in EU 2017/745 under Article 1 paragraph 12 which is
Devices that are also machinery within the meaning of point (a) of the second paragraph of Article 2 of Directive 2006/42/EC of the European Parliament and of the Council ( 1 ) shall, where a hazard relevant under that Directive exists, also meet the essential health and safety requirements set out in Annex I to that Directive to the extent to which those requirements are more specific than the general safety and performance requirements set out in Chapter II of Annex I to this Regulation.

Please guide...

Thanks ...