Legal Manufacturer Tech Files

[dj123]

Hi all.

I've very recently joined a company that has a 13485 certificate that names Company A as the certificate holder. It lists the scope for the sites as: Company A and Company B (which is a part of Company A group).

I've never dealt with the following scenario before:

Company A places onto the market with Company A as the legal manufacturer and under Company A branding. Company B places onto the market with Company B as the legal manufacturer and with Company B as the branding. The various product families from each company overlap, and they have created shared tech files for each device family. The DoC for each device family states Company A as the legal manufacturer. All labels/IFU's etc for Company B state Company B as legal manufacturer.

QNS:

1. Is there any impact from the ISO13485 certificate as Company A is the named mother company, yet we claim legal manufacturer as Company B for their products?
2. Yes, we'll need separate DoC's but is there a manner in which we can have shared tech files too?
3. In submitting for EUNB, if we are two legal manufacturers would that mean two separate submission processes?
4. Have just seen we only have one SRN code to cover both companies too.

Help!?! Please help!

 

[Orca1]

If Company B is listed as the legal manufacturer on the product labels and IFUs, it should be able to demonstrate that it has a quality management system in place that meets the requirements of ISO 13485:2016. This could potentially be achieved through the shared ISO 13485 certificate with Company A, as long as Company B's activities are within the scope of the certificate.

The standard does not explicitly prohibit shared technical files. However, each legal manufacturer must ensure that they meet all regulatory requirements for their products, including maintaining appropriate technical documentation. If shared technical files are used, it should be clear which information applies to which product and manufacturer, and each manufacturer should have control over their respective information.

Typically, each legal manufacturer would be responsible for submissions for EUNB to a Notified Body. This is because each manufacturer must demonstrate that their product meets all applicable regulatory requirements, and the Notified Body would need to assess each manufacturer's compliance separately.

 

[AnnaSokolowska]

Dear All,
I've got another problem related to Legal - Contract Manufacturer relation.
We're a manufacturer of legacy devices on the basis of OEM/PLM relationship. Our OEM designs and manufactures devices class IIa. We're preparing for MDR submission, but our Contract Manufacturer (OEM) is not willing to share his technical documents related to design and manufacturing. For design, we have only DHF and technical drawings and for manufacturing - manufacturinf flowchart. Detailed documents related to initial idea, risk analysis, conception, feasibility, design and development, verification and validation activities and manufacturing like Installation specification, in-process controls and final product testing, Incoming inspection etc are the Contract Manufacturer's business secret.
This company however already has MDR certificate for their devices.

How does it look from your experience? Would only overview documentation be enough for our MDR certification, when the Contract Manufacturer already has MDR?
Please advise, how would it look like from NB's perspective.

Thank you!

 

[Ed Panek]

Without getting into the messy details, the relationships between who is the manufacturer and the end user must be clear. The primary reason for this is post-market surveillance and the inevitable complaint cycle.

One of the primary reasons for the MDR which the UK seems to be adopting while it works out the MHRA bits is the avoidance of finger-pointing when things go poorly.