Harmonization date of IEC 60601-1 , 3rd Edition

For those that are interested, I added a new article on my website which is a summary of research on essential requirements, standards and the "presumption of conformity":
https://www.medteq.info/med/EU_ER

This research was performed some years ago as frustrated MDD auditor finding that there was rarely any scientific, systematic analysis of ERs. The surprising result was that there is no legal requirement to do so; the reason was historical and perhaps with good justification.

The legality would come from a national regulation, e.g SI 2002 No618 from the UK. They are much harder to find, and from what I can tell, they may only refer back to the respective Directives. In affect, the Directive is law, where recognized in a regulation. The article on MDD and Essential Requirements you referred to states that "If standards don't cover an essential requirement or only provide a partial solution, the manufacturer is still obligated to provide additional solutions to ensure compliance with essential requirements".

This is why using EN 14971:2009 up front to address the ER is a good start.

Marcelo's awareness of ISO 16142 is impressive and it is an interesting piece of standardization. Very few people are aware of ISO 16142, but I was a big fan of this standard when it came out, since it gave a precise alignment between GHTF Essential Principles, and other standards, including where 60601-1 could be used. It may have been too rushed to market, and although I know FDA was really promoting awareness of it, some believed it wasn't all it needed to become. My guess is, it simply didn't relate to enough standards for all the different types that would fall under more specific particularly requirements. The goal however was certainly amiable. Using one standard as a headmaster to organizing other standards, for meeting the Essential Requirements.

In fact, the only standards I've evern seen that ever successully pulled off a clean alignment with ERs are EN standards that regulate Dental Devices (EN 1639, 1640, 1641, 1642) They appear mostly as a shopping list of standards that one could potentially use to complete an Essential Requirements checklist for Dental Material, Dental Equipment, Dental Instruments, and Dental Implants. Four very broad category standards, that each show near-perfect harmony with the Essential Requirements. This is what ISO 16142 did, but as you can imagine, we'd probably need at least half dozen versions to cover all 5000 device categories (Nanotechnology anyone?).

The point is, no one standard can effectively address all the ERs and any that claim to, are misleading the users. This is why 60601-1 3rd edition had to use Risk Management, and make so many other "particular standards" "normative". It has become painfully too large and expensive for a laboratory test standard (IMHO).

Just some old news, the Q&A on the Cenelec website reappeared on the new website: ftp://ftp.cencenelec.eu/CENELEC/TCs/CollateralStandardsMDD.pdf - Thanks to Leo Eisner for pointing this out.

HELP......our question is when will the certificates as per the 3rd Editions accepted? Asia...will they accept it from 2011, 2012.,2013? Not the question of transition but the question of acceptance by the individual countries.
An answer to this would be really helpful.

Hi all
with a few days prior to the date of cessation of presumption of conformity of the 2nd edition of the standard EN 60601-1 some usual questions are:

1. How I, as a customer in Europe, may recognize that an electromedical equipment is already in compliance?

2. The electromedical products on the market are required to do something?
a) equipments in operation (ie at the hospital)
b) equipments on the distributor warehouses
c) equipments on the manufacturer warehouses

3. If I am importer in Europe from 3rd countries which documents I need to require to the manufacturer?

...


Answers

1. Each particular equipment sold by the manufacturer in Europe after 1 June 2012 must comply with the ER and so and updated Declaration of Conformity must be emitted including the references to harmonized standards (ie EN 60601-1) used as required by annex 3 of the decision 768/2008
If the product has a part 2 with not yet date of cessation arrived, include a explanation for waiting and not compliance with part 1
Also this DoC if applicable references the CE certificate emmited by a Notified Body


2.a The equipments in use does not require any action, and are legal their normal use. Remember anyway that are subjected to vigilance procedures (notification of adverse incidents)

2.b The equipments in the distributor warehouses are already placed on the market and so does not require any action, and are legal their selling and posterior normal use. Note that some Health Authorities considers the national subsidiaries as part of manufacturers and so products not placed on the market)

2.c The equipments in the manufacturer warehouses must comply with the ER and if not updated is not possible their commercialization in Europe (note that the MDD definition of commercialization include the in return
for payment or free of charge availability). Is possible to sell this equipment without the CE symbol in other countries.

3. The documents which demonstrates conformity for a electromedical equipment are:
- DoC including EN 60601-1 or disclaimer waiting for part 2
- EC certificate emmited by a NB (not for class I devices)

and you as importer need to register the product in the Healthcare National Authorities database (if required in the country you sale)

Please comment

Thanks

Xavier Canals-Riera

Hello:

Do you happen to know what the FDA's position is on legacy products and IEC60601-1?

Thank you

Check this link it may be helpful

https://www.mddionline.com/article/...why-management-should-consider-converting-now

Emilia

Thank you, but I do not see any reference to legacy devices here and I would like to know the current position FDA has on these devices. This article was written in early in 2011.

Standards are not mandatory in Europe, Canada, United States and EN 60601-1:2006 “3rd edition" is under a lot of scrutiny by the European Commission. The European Commission has fielded a lot of complaints regarding this standard in particular, mainly because some notified bodies had said that industry had to meet it for CE marking (legal compliance). This is not true.

Speaking on behalf of this issue for the European Commission, Directorate General Manfred KOHLER released the following statement October 8th 2012.

“The European Commission has repeatedly stated that standards are not mandatory in the EU system applicable to medical devices. Manufacturers may apply the Essential Requirements of the Medical Devices Directives without referring to standards. The only exception to this rule: If manufacturers choose to apply colour coding or symbols, they must use the colour coding and the symbols foreseen in the so-called harmonised standards which are cited in the Official Journal of the European Union. The European Commission follows-up reports according to which some Notified Bodies apply standards on a mandatory basis (beyond the scope of the exception)”


Manfred KOHLER
European Commission
Directorate General Health and Consumers
Unit Health Technology and Cosmetics (SANCO B 2)


The Global Harmonization Task Force has issued some helpful guidelines

GHTF/SG1/N0445.6 Alternatives to Recognised Standards

The use of standards is voluntary. Manufacturers should have the option to select alternative solutions to demonstrate their medical device meets the relevant Essential Principles. Manufacturers may use “non-recognised” standards, in whole or in part, or other methods. Alternative means of demonstrating conformity with the Essential Principles may include, for example:

• national and international standards that have not been given the status of a "recognised standard" by the Regulatory Authority;

• industry agreed methods;

• internal manufacturer standard operating procedures developed by an individual manufacturer;

• other sources that describe the current state of technology and practice related to performance, material, design, methods, processes or practices(3).

When meeting the Essential Requirements, it is wise to take into consideration the GHTF guidance. Regulatory representatives from the European Union, United States, Japan, Canada and Australia co-created it. Their guidance may also prevent some very costly testing and unnecessary re-testing. The European Commission has been responding to numerous complaints from industry regarding the cost 60601-1 3rd edition and the misinformation they had been observing from certain advertisement, articles, etc, from certain testing labs and notified bodies. Enough complaints from industry finally reached a point where the European Commission undertook a careful review, not only of 60601-1 3rd edition, but the use reliance on standards in general. I spoke with a top-most representative of notified bodies who is fairly convinced that certain standards like this one may actually be replaced by a European Regulation.

EN 60601-1:2006 3rd edition has been found to be sorely lacking in its claimed ability to satisfy the ER. EN 60601-1:2006 will likely be withdrawn, and if it is replaced, it will have a very different looking Annex Z, similar to that of EN ISO 13485:2012 and EN ISO 14971:2012, which are far more carefully drafted to show where precisely the standard may, or may not be used for meeting the Essential Requirements of the Directives concerning medical devices.

The FDA's approach is different to Europe. In the USA, standards are not part of the law, rather the FDA simply says they promise to process your 510(k) or PMA quickly if you use standards.

Once the 510(k)/PMA is approved (clearance for sale), that's it. The device is in principle allowed to be marketed forever, provided you don't make any design changes.

If you make a design change, the FDA gets a bit warm and fuzzy and not really clear (highlighting the lack of legal backbone behind the use of standards).

See (broken link removed), Items 9 and 11.