Standards used for Medical Device MDD Technical Files

S

SteveK

Hi,

This is my first plunge into the forum.
On joining my company nearly a year ago, I inherited a series of Technical Files as part of the company’s MDD 93/42/EEC Class II conformity requirements for CE marking. I’ve put a lot of effort into reviewing and updating them. The previous incumbent based these; as one might expect, on published Standards (ISO, BS, EN or combination) for the particular medical device type e.g. Medical Gas Pressure Regulators. Tests etc were conducted as referenced in the Standard and reported. However, many of our products have been around for many, many years. Standards that were used have almost all been updated, merged, replaced, split up etc since the original evaluation. If they were new products, in lots of cases they would now be tested to different test specifications, limits, additional tests etc. If nothing has actually changed to the devices, in people’s opinion, should we have to retest everything to what are continuing moving goal posts? This would natuarally constitute a lot of work/resources.

Thanks.
 
M

MIREGMGR

Re: Standards used for Technical Files

In the FDA world, compliance to a standard is determined at a point in time, and thereafter is an historical fact as of that point in time...just as FDA approval of a 510(k) application is an historical fact at a point in time.

Thus for FDA purposes, compliance is to a particular version of a standard...not to whatever version is current as of a later date when the original approval is relevant to some later decision process. Similarly, a 510(k) once granted is a fact, even if the FDA later changes its guidelines, recognizes new consensus standards, changes product classifications, etc.

Thus there is no basis for continual updating of past standards compliance processes as a standard evolves.

I believe that 13485 and MDD utilize a similar conceptual basis.
 

Marcelo

Inactive Registered Visitor
Re: Standards used for Technical Files

Well, i disagree a little with miregmgr. The requirements of safety standards are risk controls options for manufacturers. If the requirements change, it means that means to control the related risks have changed (the consensus means, i mean). If there´s new requiremnts, it means that new risks have been found and should be dealt with. In the case where the means have changed, you can always justify in your risk management that the older means of risk control (the older requirements) are still valid for you product (which i doubt because the were replaced). In the case of the new risk control, your risk management has to deal with them in some way, but just can´t ignore them (if the risks aply to your equipment).
 
M

MIREGMGR

Re: Standards used for Technical Files

This is a complicated question.

When a standard changes substantially, and is the basis for design of a complex, expensive, low-volume medical system, it may not be economical to redesign the product to the new standard.

As an example, radiolucent structural tabletops used for diagnostic imaging that have been designed to IEC 60601-1 Second Edition or 60601-2-46 First Edition with maximization of their radiolucency performance by means of minimized structural-design compliance with the standard's rated patient load distribution, will not be sensible designs under 60601-1 Third Edition. Structural/radiolucency redesign would be required if the design is to be marketed as compliant with the updated standard.

And certainly for Class II products with long service lives for which the 510(k) was approved under a previous version of a standard, the scope of which arguably does not invalidate the fundamental safety and effectiveness of the system's intended use (for instance, a change to the standard governing the patient table structural-capability/radiolucency performance balance for a CT system), few manufacturers are going to be financially able to re-design the tabletop and build new tools for further sales of a system that no longer is the flagship product. Neither is such a manufacturer going to be eager to update systems already in the field.

I've received an interpretation from the FDA that a 510(k) application approval, once granted, is fixed in place. We were told that the FDA, as policy, does not re-visit existing 510(k)s. Our inquiry was in regard to ProCode MMP sterile barrier disposables.

OTOH, for a device with ongoing marketing, a change to regulatory requirements that amounts to identification of a previously unrecognized risk or otherwise calls into question whether the device currently is safe and effective, certainly would seem to need attention.

I'm aware of no specific regulatory Guidance from either the FDA or European authorities on this question. It might need legal input in specific circumstances.
 
S

SteveK

Re: Standards used for Technical Files

Thanks for the feedback.

We do not market in the US so 510(k) does not apply, however the precedent you have indicated might still be a useful backup from an audit standpoint (we are ISO 13485 and ISO 9001 accredited). It is interesting that you quote 60601-1. For one electrical device we had external testing conducted to the 1990 version and now it is the 2006 issue. Another example of the impact is that a product range we have marketed for years i.e. medical gas pipeline terminal units, are stamped internally with the reference standard (BS EN 737-1:1998), have an external label carrying the standard reference and it is referenced in our accompanying literature. In the last month this standard has been withdrawn and replaced with BS EN ISO 9170-1:2008 – which is a further headache, though the standard's requirements are very similar. Other manufacturers also reference standards in their literature/websites which are no longer current. We also, for example, even still reference the previous quality standard (and in our technical files), i.e. BS EN 46001, which has been obviously superseded by BS EN ISO 13485. This latter case is not such a problem due to our current accreditation. Similarly, I have not come across any regulatory guidance, but it must be a medical device industry wide problem seeking resolution.
 

Al Rosen

Leader
Super Moderator
Re: Standards used for Technical Files

Based on Annex 1 Essential Requirements point 2, I believe you need to update based on revisions to the standards.

The solutions adopted by the manufacturer for the design and
construction of the devices must conform to safety principles, taking
account of the generally acknowledged state of the art.

In selecting the most appropriate solutions, the manufacturer must
apply the following principles in the following order:
— eliminate or reduce risks as far as possible (inherently safe design
and construction),
— where appropriate take adequate protection measures including
alarms if necessary, in relation to risks that cannot be eliminated,
— inform users of the residual risks due to any shortcomings of the
protection measures adopted.
 
M

MIREGMGR

Re: Standards used for Technical Files

For one electrical device we had external testing conducted to the 1990 version and now it is the 2006 issue.

Presumably the third-party test report states the standard version to which compliance was established. The recipient of that test report presumably will determine, via rule or policy, whether that report remains valid once issued, or only as long as the applied standard version remains in force.

In the US marketplace, UL historically issued certifications to medical electrical systems, in the form of Labeling or Listing. Issuance of a UL Listing permission was for an indefinite period. Companies that had obtained Listing were only rarely required to subsequently update their designs, even though UL utilized (and played a major role in writing and maintaining) the U.S. National Electrical Code as a key guidance document and that standard had a three-year revision cycle.

UL remains active as a test laboratory, of course. They still issue certifications of compliance, now to 60601-1, though to a uniquely-UL-customized version. As far as I know, their certifications are not specified to expire if/when UL revises their 60601 interpretation to take into account the 60601-1 Third Edition changes. At present, UL 60601-1 is not identified as to version.

A mandatory regulatory interpretation that existing regulatory compliance terminates when any applicable standard is updated would be very difficult to apply from a regulatory-economics perspective, since standards' revision cycles are not synchronized. The engineering design of complex systems would never be finished.

On the other hand, obviously medical device risk must be managed to a reasonable level of safety and effectiveness. It's a complicated problem.
 
A

Adele

Re: Standards used for Technical Files

Al is right - the overiding factor here is maintaining your product to state of the art.

The concept of state of the art is not a line in the sand. The line moves as standards move. A medical manufacturer is expected to keep pace with the moving line.

When a new revision of a standard becomes available, you need to review the new standard against the old one so to determine if any additional testing/work is required to claim compliance to the new revision of the standard.

There is a published list of harmonised standards for the EU. As standards are revised, the older standards drop off this list - http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/reflist/meddevic.html.

You say in your original post "If nothing has actually changed to the devices, in people’s opinion, should we have to retest everything to what are continuing moving goal posts?" - even though nothing has changed to the device, the standards that apply to the device probably have and you need to be able to display compliance to the latest version of the device.

And yes, that does involve continually moving goal posts but as the information in the industry changes the standards are changed to reflect that.
 

jkuil

Quite Involved in Discussions
Re: Standards used for Technical Files

For the FDA's opinion on this read Guidance for Industry and FDA Staff - Frequently Asked Questions on Recognition of Consensus Standards, especially Q8-11.

If any standard that has been used to claim conformity to the essential requirements of safety and effectiveness has been changed and the actual change involves safety and effectiveness requirements than a risk assessment should be performed. This may involve re-evaluation of existing verification and validation data, or even retesting of the product. If the residual risks with the product becomes inacceptable, appropiate measures should be taken. If the change does not seriously affect the safety and effectiviness of your product you must document your justification for referring to outdated documents.

When the EU notifies a revised standard has been harmonised, they also says when the application of any previous standard becomes unacceptable. This date is the 'date of cessation of presumption of conformity of the superseded standard' - the 'docopocoss'. After this date, a manufacturer must not ship any products conforming only to the old standard, but distributors (and retailers) have about a year to dispose of stocks.

Notified bodies must evaluate whether the products have remained state of the art during their audit of the quality system according Annex II 3.3 of the MDD,
PHP:
The notified body must audit the quality system to determine whether it
meets the requirements referred to in Section 3.2. It must presume that
quality systems which implement the relevant harmonized standards
conform to these requirements.
The Notified Body must evaluate a sample of technical files.
 
M

MIREGMGR

Re: Standards used for Technical Files

If any standard that has been used to claim conformity to the essential requirements of safety and effectiveness has been changed and the actual change involves safety and effectiveness requirements than a risk assessment should be performed. This may involve re-evaluation of existing verification and validation data, or even retesting of the product. If the residual risks with the product becomes inacceptable, appropiate measures should be taken. If the change does not seriously affect the safety and effectiviness of your product you must document your justification for referring to outdated documents.

I disagree a bit with the interpretation inferred here. The FDA's regulatory stance is capsulized in Answer 9, "Changes in a recognized standard do not retroactively affect a product’s clearance or approval status." The content of Answers 10 and 11 is advisory only. In the absence of a Special 510(k) filing for a change to a previously approved Class II device or special circumstances such as a For-Cause FDA inspection/audit after a report of a death or serious injury, there is no FDA mechanism for reviewing or approving any such advised actions.

In particular, "must document" never appears in the FDA language, which scrupulously follows the advisory "should" and "may" language practice.

There also is no specific reference to performance of a risk analysis per se. The FDA still does not require inclusion of a risk analysis in a Class II 510(k) regulatory filing, whether Traditional for a new device or Special for a modified one.

It's obvious to me at this point that I had an incorrect understanding of the thrust of 13485/MDD in this regard when I first posted in this thread to the effect that I thought the 13485/MDD stance was similar to that of the FDA. The products that we sell into the EU are all Class I, mostly are not subject to external standards other than 10993 and 11135 where we have other motivations to keep ourselves harmonized, and mostly are sold through OEMs who treat them as accessories to devices for which they are the manufacturer, thus our 13485/MDD focus is primarily on the manufacturing end and sometimes isn't as sharp as it should be. Mea culpa.

In any case, the FDA and EU are far from harmonized on this issue.
 
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