Any examples of National or Regional Regulations referred to in ISO 13485?

M

micaudwell

#1
Hi
There are numerous references in ISO 13485:2003 detailing provisional requirements contingent on national or regional regulations, including for example:

6.2.2 Note - National or regional regulations might require the organization to establish documented procedures for identifying training needs

8.1 NOTE - National or regional regulations might require documented procedures for implementation and control of the application of statistical techniques

8.5.1 If national or regional regulations require notification of adverse events that meet specified reporting criteria, the organization shall establish documented procedures to such notification to regulatory authorities.

I would be obliged if anybody can provide examples such national or regional regulations.

Many thanks
Mike Caudwell
 
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Doug Tropf

Quite Involved in Discussions
#2
Re: National or regional regulations

21 CFR 820 - FDA Medical Devices Quality System Regulation is an example of a national regulation.
 

Ajit Basrur

Staff member
Admin
#3
Hi
There are numerous references in ISO 13485:2003 detailing provisional requirements contingent on national or regional regulations, including for example:

6.2.2 Note - National or regional regulations might require the organization to establish documented procedures for identifying training needs

8.1 NOTE - National or regional regulations might require documented procedures for implementation and control of the application of statistical techniques

8.5.1 If national or regional regulations require notification of adverse events that meet specified reporting criteria, the organization shall establish documented procedures to such notification to regulatory authorities.

I would be obliged if anybody can provide examples such national or regional regulations.

Many thanks
Mike Caudwell
Hi Mike,

With regards to United Kingdom, you can refer to the Medicines and Healthcare producers Regulatory Agency (MHRA) website and refer to the section "How we Regulate Medical devices" http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=48 - its quite detailed and also gives links to -

1. European Commission (http://ec.europa.eu/enterprise/medical_devices/index_en.htm)

2. Office of the Public Sector Information (OPSI) http://www.opsi.gov.uk/index.htm
 
M

micaudwell

#4
Hi
Regrettably I think I might not have made myself completely clear. What I was looking for specifically was an example (or examples) of a national or regulation which mandates the establishment of a documented procedure for identifying training needs, say.

The UK Medical Devices Regulations ought to be considered a medical device in themselves as a cure for insomnia - I was rather hoping that some poor soul with greater stamina than me might be able to quote national or regional regulation that answered my original (rather vaguely put) query.

Thanks again

Mike
 

burovoy

Starting to get Involved
#5
Hi
What I was looking for specifically was an example (or examples) of a national or regulation which mandates the establishment of a documented procedure for identifying training needs, say.
FDA:

21 CFR 820.25 Personnel

(b) Training. Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented.

21 CFR 820.250 Statistical techniques.
(a) Where appropriate, each manufacturer shall establish and maintain procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics.


Hope this helps:2cents:
 
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R

Roland Cooke

#6
Hi Mike, que pasa?!

The FDA quotation is an interesting example, because I often raise Observations (and occasionally NCs) under ISO13485 6.2.2 against US companies that have previously only had experience with compliance to the QSR.

I am often given a list of procedures that have been given to the trainee to read, and signatures confirming that the trainee has read those procedures.

Unfortunately ISO13485 talks about competency determination (of requirements) / evaluation / re-evaluation, which is not exactly the same thing. An evaluation of effectiveness is also required.

My guess is that that footnote was put in specifically with the FDA QSR in mind.


As for the adverse incident reporting, those requirements will inevitably be different for each country / region. (Note that Europe is a region).
 
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M

micaudwell

#7
Hola Rola & others who have kindly responded

I think its fair to say that the language used in the standard (most if not all standards in fact) tends to be dense and on occasion cryptic. This leaves mere mortals such as myself having to try to divine the meaning without having access to the original intention of the author(s).

I believe it is the case that notes of the sort about which I enquired have been included to allow for general applicability of the standard across various jurisdictions without introducing any element of compulsion (a sort of one size fits according to your choice of bits).

I have no direct routine contact with the US CFRs and so remain relatively innocent of their requirements, but it if the notes are read with, say, 21 CFR 820.25 or 21 CFR 820.250 in mind it all fits together.

Thanks and regards

Mike Caudwell
 

Marcelo

Inactive Registered Visitor
#8
You can always try reading ISO/TR 14969:2004, which provides guidance for the application of the requirements for quality management systems contained in ISO 13485
 

Weiner Dog

Med Device Consultant
#9
Hi
There are numerous references in ISO 13485:2003 detailing provisional requirements contingent on national or regional regulations, including for example:

6.2.2 Note - National or regional regulations might require the organization to establish documented procedures for identifying training needs

8.1 NOTE - National or regional regulations might require documented procedures for implementation and control of the application of statistical techniques

8.5.1 If national or regional regulations require notification of adverse events that meet specified reporting criteria, the organization shall establish documented procedures to such notification to regulatory authorities.

I would be obliged if anybody can provide examples such national or regional regulations.

Many thanks
Mike Caudwell
Under the US Food Drug and Cosmetic Act, certain medical device companies have to comply with this law + various regulations under the Code of Federal Regulations Part 21. These regs include:

21 CFR 801- Labeling
21 CFR 803- Medical device reporting (MDR's) (reported to FDA) (equal to your 6.22 note)
21 CFR 806- Corrections and removals (CAR's) (certain CAR's reported to FDA)
21 CFR 807- Site registrations and product listings (submitted to FDA)
21 CFR 809- Invitro diagnostic devices (IVD's)
21 CFR 812/814- Investigational device exemptions (IDE's) and Premarket approval of medical devices (510(k)'s and PMA's) (submitted to FDA)
21 CFR 820- The Quality System Regulation (QSR) (your 8.1 and 8.51 notes are contained in the QSR).
21 CFR 821- Medical device tracking (reported to FDA)

The QSR is an umbrella GMP (i.e. flexible regulation that can encompass all types of operations and products). FDA does not state how to conduct the various operations or requires companies to follow any guidelines (such as the GHTF or FDA process validation guidelines) or standards (such as ISO, AAMI, or ANSI). However, if a company wishes to follow these guidelines or standards, they may do so voluntarily.

Refer to http://www.fda.gov/cdrh/devadvice/ and http://www.fda.gov/cdrh/databases.html for additional information.
 
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