MHRA - Virtual Manufacturer Document Requirements

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Hi all

I have been reading through the MHRA's document "Virtual Manufacturing replaces Own Brand Labelling for medical device manufacturers" which was published in March 2017.

We manufacture a number of devices which we manufacture and then sell to customers who then CE mark the product themselves.

It is my understanding that they would be defined as "virtual manufacturers" and therefore we would be required to provide full technical documentation to ensure they meet the regulatory requirements.

Is it correct to assume that this would include all documentation which is required to meet the essential requirements? As an example this would include among other documents:

• Design verification and validation

• Risk assessment

• Biocompatability

• PMS

• CER

• Manufacturing and sterilisation process validation documentation

This would result in a large number of confidential documents which we would need to provide to our customers.

Additionally, this would mean that we would have to continually update them with documentation whenever it was updated.

Am I understanding the requirements properly?

Thanks in advance for the help!

 

[pkost]

Re: MHRA - Virtual Manufacturer

The MHRA document says that the virtual manufacturer must hold a complete technical file and further references the NB-MED guidance (link) on what constitutes a technical file

The MHRA document further goes on to state:

In the case of virtual manufacturing where the manufacturer does not hold the rights related to product design, the notified body and Competent Authorities may accept a technical file from the virtual manufacturer that has redacted proprietary information as long as the redacted information is not essential for the purposes of the notified body or Competent Authorities assessing whether the medical device complies with the regulatory requirements. Redactions should be as limited as possible.

In cases where the virtual manufacturer holds redacted technical documentation they must have contractual arrangements to ensure full disclosure of all applicable information by the Original Equipment Manufacturer (OEM) directly to the notified body of the virtual manufacturer (without the further need for agreements to be put in place between the notified body and the third party OEM).

The following may constitute proprietary information:
a. Unique material formulae or ingredients which are specific to the medical device and not in general use which are of high commercial and intellectual benefit to the OEM
b. Unique manufacturing processes which have been designed by the OEM and give them a competitive advantage in the market place
c. Technical drawings and technologies (applicable where a patent is also being applied for) but not yet granted
d. Software algorithms

Note: Full redaction of all formulas, ingredients, algorithms or manufacturing processes cannot be accepted. Where redactions are made then the justification for these redactions by the OEM must be documented and the top level information provided should be sufficient to understand the medical device and any associated risks.

Any technical documentation provided to a notified body should include a statement drawn up by the virtual manufacturer indicating they fully understand all the documentation provided and that they accept full legal responsibility

As a virtual manufacturer I would expect you to provide me with controlled copies of documentation, however I don't always trust my OEMs to do this effectively and I'm now much more clearly responsible for my own technical file. As a virtual manufacturer I could probably justify not having controlled copies linked to yours....I can update my own documents now independent of your's...the document only requires changes to product and PMS /vigilance information to be transmitted.

 

[MIXOLYDIAN]

This info was very useful for me during a compilation of data for a Tech File review. I'm very thankful for this post.

Luis