Is Site Master File necessary for a European Medical Device Manufacturer (class III)?

Hi folks,

working for a medical device manufacturer (class III) in Europe with focus on FDA-market, I want to know if there is something like a Site Master File necessary for medical device industry.

I´ve been doing Quality Management for pharmaceutical industry for several years and there a Site Master File is a basic element. It is a more or less detailed description of the firm, its manufactured products, materials, processes, equipment, personnel, sales, etc.

Now doing QM for medical devices, i wonder if there is something similar for MD because I found it very useful and it was handed out to notified bodies or other inspectors to give a "global overview".

Can anybody tell me, if I need a Site Master File in medical device industry?And where is the corresponding requirement (FDA, DIN EN ISO, etc.)?

Thank´s a lot
Cosma

Re: Site Master File

I do not think Site Master File is required for Medical devices - its definitely required for manufacturing sites supporting Pharmaceuticals.

I am attaching a link to the PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME (PIC/S) document on Preparation of a Site Master File . In this document, section 2.1 clearly states the following -

The Site Master File is prepared by the manufacturer and contains specific
information about the quality assurance, the production and/or quality control of pharmaceutical manufacturing operations carried out at the named site and any closely integrated operations at adjacent and nearby buildings. If only part of a pharmaceutical operation is carried out on the site, a Site Master File need only describe those operations, e.g. analysis, packaging, etc.

Even the MHRA - Preparation of SMF refers to Pharmaceuticals only.

Re: Is Site Master File necessary for a European Medical Device Manufacturer (class I

It is not a requirement, but it may come in handy in MD-companies with multiple sites.

Re: Is Site Master File necessary for a European Medical Device Manufacturer (class I

Cosma said:

working for a medical device manufacturer (class III) in Europe with focus on FDA-market, I want to know if there is something like a Site Master File necessary for medical device industry.

Click to expand...

Hi Cosma,

The nearest I have found to a SMF in medical devices is the Site Quality Plan required by the USFDA QSR's (21CFR820.20(d))

Quality planning: Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured. The manufacturer shall establish how the requirements for quality will be met

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which isn't massively dissimilar to a SMF. I like having either a SMF or a SQP because it is a useful reference source for the site and it helps internal auditor get up to speed with the site level QMS.

Jimmy

Re: Is Site Master File necessary for a European Medical Device Manufacturer (class I

yes master file is required

Re: Is Site Master File necessary for a European Medical Device Manufacturer (class I

Sam - Can you cite what document (or regulation or whatever) requires one?