How do Medical Device Standards vs Directive vs Regulation technically vary?

G

Gargi

#1
Hello Elsmar,:bigwave:

How do Standards , Directive and Regulations (in medical device aspect) vary technically amongst each other.

I did a lot of search earlier but couldnt arrive at firm and accurate distinction.:nope:

Any help is genuinely appreciated.

Thanks and regards,
Gargi
 
Elsmar Forum Sponsor

Sarah Stec

Involved In Discussions
#2
Re: Standards v/s Directive v/s Regulation

Is your question as to the kind of information they contain?

If so, in my opinion, you can look at standards as more detailed or technical version of the directives and regulations. The directives and regulations give you the requirements; the standards point you in the direction (and sometimes outright tell you) of meeting the requirements (for harmonized standards). So, directives and regulations don't have a lot of technical information, whereas standards do.

As an example, a directive or regulation is going to say, "the device must be safe." If you think about it, this is actually an incredibly broad statement. So the standard is going to tell you "this is a safe voltage, this is how you test the device to make sure it's safe, this is how many samples you need to test, these are the results you're looking for, etc."

Directives and regulations are types of EU pieces of legislation (well, directives are, and regulations are universal, but we'll focus on the EU). A directive is directed towards the member states, and must be adopted and transposed by each member state into its own laws. For medical devices, most of the MDD was transposed exactly how it is, but the member states have differing provisions for things like device registration. A regulation, on the other hand, is effective upon all member states exactly how it is written; there is no need to transpose the regulation into member state's codes because it is already legally binding as it is.

There are a lot more differences between standards and the regulatory texts (who creates them, who follows them, who adopts them, harmonized vs. not-harmonized standards, effects of country-specific standards, etc.). Did you mean something else? :cool:
 

Ronen E

Problem Solver
Staff member
Moderator
#3
Generally, regulations are elaborations of laws or established hi-level policies. They're usually drafted not by the legislating authority (eg Parliament) but by an executive body (eg the FDA, the Minister of health etc.) empowered to do so in/by the relevant law.

In the EU, "Regulations" are a specific type of legislative instrument, as Sarah has explained. "Directives" are another type of legislative instrument (as Sarah has explained as well).

Published standards (assuming that this is what you were referring to) are exactly that - a formalised written expression of some (usually broad) agreement on a topic. Some regulations (and some EU directives) rely on specific standards instead of going into a lot of detail, but published standards don't necessarily relate to any regulatory / legal process or requirement. Some standards are just a reflection of a broadly-accepted "state of the art", while others are just tools (among others).
 
G

Gargi

#4
Re: Standards v/s Directive v/s Regulation

Hi Sarah,

Thank you for detailed info.

However consider this case:
Directive 93/42/EEC (Medical device directive ) and Standard IEC 60601-1 (basic safety and essential requirements) both explain in detail the essential requirements of medical device.
I know that MDD is concerned with just Europe and IEC is a global standard.
Then on what grounds can I differentiate them.

I appreciate if you could clarify me on in this aspect


Thank and regards
Gargi
 
G

Gargi

#5
Generally, regulations are elaborations of laws or established hi-level policies. They're usually drafted not by the legislating authority (eg Parliament) but by an executive body (eg the FDA, the Minister of health etc.) empowered to do so in/by the relevant law.

In the EU, "Regulations" are a specific type of legislative instrument, as Sarah has explained. "Directives" are another type of legislative instrument (as Sarah has explained as well).

Published standards (assuming that this is what you were referring to) are exactly that - a formalised written expression of some (usually broad) agreement on a topic. Some regulations (and some EU directives) rely on specific standards instead of going into a lot of detail, but published standards don't necessarily relate to any regulatory / legal process or requirement. Some standards are just a reflection of a broadly-accepted "state of the art", while others are just tools (among others).
Hi Ronen,

Thank you for detailed info.

However consider this case:
Directive 93/42/EEC (Medical device directive ) and Standard IEC 60601-1 (basic safety and essential requirements) both explain in detail the essential requirements of medical device.
I know that MDD is concerned with just Europe and IEC is a global standard.
Then on what grounds can I differentiate them.

I appreciate if you could clarify me on in this aspect


Thank and regards
Gargi
 

Marcelo

Inactive Registered Visitor
#6
The most basic answer is, standards are generally voluntary and regulations (which include directives, ordinances and anything published by a government body) are mandatory.

Regulations usually details general expectations/requirements (what) and standards usually details application of those (how) or more detailed requirements related to the general expectations requirements.

A simple example, EU regulations are based on the concept of essential requirements, which are high level expectations. One essential requirement (in 12.6. Protection against electrical risks) is that "Devices must be designed and manufactured in such a way as to avoid, as far as possible, the risk of
accidental electric shocks during normal use and in single fault condition, provided the devices are installed correctly".

This essential requirement (as most of the others) is so generic that it's not easy to comply with. Anyway, you can comply with any good engineering solution that does fulfill the requirement.

One way to comply is to comply with the more detailed technical requirements of IEC/EN 60601. More specifically, you would need to comply with 8 * Protection against electrical HAZARDS from ME EQUIPMENT .

So, what the standard does in this case is to clarify, in a more explicitly way, how to comply with the more generic essential requirements.

For more on the link between directives and standards, please read the the 'Blue Guide' on the implementation of EU product rules.
 
G

Gargi

#7
The most basic answer is, standards are generally voluntary and regulations (which include directives, ordinances and anything published by a government body) are mandatory.

Regulations usually details general expectations/requirements (what) and standards usually details application of those (how) or more detailed requirements related to the general expectations requirements.

A simple example, EU regulations are based on the concept of essential requirements, which are high level expectations. One essential requirement (in 12.6. Protection against electrical risks) is that "Devices must be designed and manufactured in such a way as to avoid, as far as possible, the risk of
accidental electric shocks during normal use and in single fault condition, provided the devices are installed correctly".

This essential requirement (as most of the others) is so generic that it's not easy to comply with. Anyway, you can comply with any good engineering solution that does fulfill the requirement.

One way to comply is to comply with the more detailed technical requirements of IEC/EN 60601. More specifically, you would need to comply with 8 * Protection against electrical HAZARDS from ME EQUIPMENT .

So, what the standard does in this case is to clarify, in a more explicitly way, how to comply with the more generic essential requirements.

For more on the link between directives and standards, please read the the 'Blue Guide' on the implementation of EU product rules.
Thank you Marcello for that indepth yet precise distinction between standards and regulations.

I am really Glad that Elsmar reopend again.
I believe that ELSMAR IS PHOENIX that would always rise back in any adverse situation.

I wish ELSMAR to live long.

Best Regards,
Gargi
 

Sarah Stec

Involved In Discussions
#8
Re: Standards v/s Directive v/s Regulation

However consider this case:
Directive 93/42/EEC (Medical device directive ) and Standard IEC 60601-1 (basic safety and essential requirements) both explain in detail the essential requirements of medical device.
I know that MDD is concerned with just Europe and IEC is a global standard.
Then on what grounds can I differentiate them.
Marcelo's explanation is a good one. I would add a few corrections to what you say above to hopefully help your understanding:

- The MDD states (not explains) the essential requirements of medical devices. However, as Marcelo stated, these essential requirements are generic and very broad because they apply to all medical devices, from gauze to pacemakers. You could imagine that proving a piece of gauze or a bandage is safe and effective requires different information than proving a pacemaker is safe and effective. This is why there are standards.
- The harmonized standards (like EN/IEC 60601-1) explain in detail how the medical device for which the standard was written could meet the essential requirements.

-Another way to differentiate them: The MDD is mandatory to follow, whereas IEC 60601-1 is not. You can comply with IEC 60601-1, but if you don't follow the rest of the MDD requirements, then you aren't compliance with the MDD. Directives =/= Standards.

I hope this is helpful!:cool:
 
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