Technical File Format - MEDDEV 2.5.1

[AOIRA]

Just an FYI. We distribute devices in both U.S. and E. U. A recent conformity assessment by our Notified Body revealed that our Technical File format was not best practice. Specifically, we combine our Technical File with our DMR and call Part A the Technical File and Part B the DMR. His suggestion was to have a standalone Technical File with Part A of the file being a single controlled document known as the Summary of Essential Technical Data, and Part B being a combination of physical documents unique to a Technical File (Essential Reg Checklist, NB cert, clinical eval, etc,) and an index of the technical data documents already contained in the DMR for the device (to avoid duplication).

Guess I never fully understood MEDDEV 2.5.1.


David

 

[Marcelo]

Weird.

Before anybody asks, he´s dealing with medical devices, and DMR stands for device master record, a set of documents required by the FDA and other legislations (but not CE marking).

 

[Peter Selvey]

Just some history here for anyone interested:

The document in question is NB-MED2.5.1/Rec 5. This is not a MEDDEV, which means it is not endorsed by the EU government. According notes on found in a report on the NBOG website (see section 3.3), this particular NB-MED has been reviewed and changes have been requested before consideration as a MEDDEV. Buy so far I have not yet found the content of the changes.

The Part A and Part B has a historical basis. An earlier "Blue Guide" (covering the new approach directives for CE marking) assumed that companies outside the EU would have to keep a copy of the technical file with the EU representative. To limit the volume of documents, this earlier guide proposed splitting the file into Part A and Part B with only Part A retained by the EU representative.

The final version of the "Blue Guide", published in 2000, clearly states that there is no requirement to keep the technical documentation in the EU (see page 50). As such, the Part A/Part B split was also removed.

The NBs nevertheless took the Part A/Part B concept and it remains in the NB-MED, and it makes sense to (a) define the initial set of material to be sent to a NB if requested, and (b) define what needs to be translated where the NB cannot understand the language of the manufacturer.

I find that the GHTF STED guide (DEAD LINK = http://www.ghtf.org/documents/sg1/sg1final-n11.pdf - See attachment) explains it better: it makes it clear that this is not two seperate files, rather there is a full "technical file" which contains everything; and there is a "summary" that can be used for initial regulatory submissions, with translation if needed. After this summary is reviewed, the regulatory agency then may start to ask for additional documents from the full technical file, e.g. for a particular area of interest, or just random sampling.

Nevertheless, none of this is law: the real content of technical documentation (file) in the MDD is specified in the relevant Annex, for example Annex II, Section 3.2 (c).

Always make sure you comply with the law, and use the guide as a guide.

 

[gramaley]

The "Technical File" requirements are listed in Section 3 of Annex VII of 93/42/EEC. The Annex II section 3.2 c) documents are more related to supporting the ongoing maintenance of the product, including procedures within the QMS. Certainly there is some overlap here with the Technical File documents of Annex VII.

I do agree however that the DMR is an extension of the Technical File, and I have found our engineers preferring to have the Design History File and Technical File together. The reason for that is, a lot of the design input comes from regulatory requirements that are derived from Annex I or output from the Risk Management File (which is part of the TF), and certain standards that are to be considered. So there is a lot of overlap between the QMS - Design Control activities, Document Control and the EU "Technical File" of Annex VII.

The reality is, the DMR should not be in the Technical File, unless your document control system is so small, it can manage all the drawings and labeling, software specs out of a notebook. A whole "Technical File" can be small enough to fit into a notebook or two, in most cases.

Happy New Year!