Penalty for Non Compliance to EN Standards

Hi everyone,

My company had a few technical files for our CE mark medical devices and there were some new EN standards that my company were unable to comply at this time. So I had a few questions:

1) Is there any penalty for not complying to the EN harmonized standard?

2) What is the penalty for quoting a standard in our technical file ER checklist which my company did not comply to?

3) If my company really cannot comply with the new standards, can we just quoted the withdraw version instead?

4) Last of all what is the differences between EN ISO and ISO?

Any help is greatly appreciated.

Interesting questions. Let's see if we can all figure this out together.

1) Is there any penalty for not complying to the EN harmonized standard?

Not specifically, but if you cannot otherwise prove to your Notified Body that you meet the Essential Requirements (ERs) of the applicable Directive, your right to apply the CE marking could be taken away. It is required to meet the applicable Essential Requirements (ERs) of the applicable European directive. Compliance with the harmonised standards, while not required, provides ‘presumption of conformity’ with the corresponding ERs. The alternative is somehow prove to the Notified Body that you meet the ERs in your own special way.

Here is some related info extracted from an EU guidance document on the New Approach Directives attached to a previous thread:
"The application of harmonised standards that give a presumption of conformity remains voluntary.The manufacturer can choose whether or not to refer to harmonised standards. However, if the manufacturer chooses not to follow a harmonised standard, he has the obligation to prove that his products are in conformity with essential requirements by the use of other means of his own choice (for example by means of any existing technical specifications). If the manufacturer applies only a part of a harmonised standard or the applicable harmonised standard does not cover all the essential requirements, the presumption of conformity exists only to the extent the standard corresponds to the essential requirements."

2) What is the penalty for quoting a standard in our technical file ER checklist which my company did not comply to?

I would not advise you to claim conformance to a standard that you do not conform with. There is a reasonable chance that your Notified Body (NB) would view this as a nonconformity. Perhaps you partially conform and can explain what aspects of the standard you do and do not conform with.

3) If my company really cannot comply with the new standards, can we just quoted the withdraw version instead?

I would prefer this over falsely claiming conformance to the current standard. This has to do with the "state of the art" and could be is tricky.

Since all standards are voluntary, there should be nothing wrong with claiming conformance to the older version of a standard. However, you might run into a concern from your NB that you are not in compliance with the first paragraph of MDD ER2 which states:
"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."

I wonder how NB's are going to deal with this.

4) Last of all what is the differences between EN ISO and ISO?

In my experience, the EN ISO version is typically identical to the corresponding ISO version except the year of the EN ISO version may be later, and the EN ISO version has an INFORMATIVE annex (not NORMATIVE annex) called something like this: "Relationship between the European Standard and the Essential Requirements of EU Directive 93/42/EEC". There is a table in this informative annex that cross-references the clauses of the standard to the ERs of the Directive. These cross-references are overly abundant in my opinion but they could be helpful for preparing an ER Checklist.

Here is an example of a standard where the EN ISO version only differs from the ISO version as I have indicated above.

EN ISO 11607-1:2009 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)

Sam is correct. A little more general information:

The penalties under EU Directives are for not meeting the Essential Health and Safety Requirements in the Directive. One of the defences in the event of a legal action is by claiming compliance with European standards as they define industry standards at the time.

I agree you should not claim compliance to a standard that you do not meet. My guess is that in the case of legal action you would become subject to punitive damages for knowingly supplying product that does not meet the standard.

On the subject of ISO vs EN ISO - because these are European Directives any legislation refers to European standards and, as Sam mentioned, this provides a 'presumption of compliance' defence. Compliance with an ISO standard could form part of a defence but would not be the whole deal. Standard numbering and development works like this for standards that are to be international:

• The 'main' work is done by ISO (through a series of technical committees made up of representatives from national standards bodies - such as BSI in the UK). When ready it is issued as ISO xxxxxx
• The standard is adopted as a European Standard when the European standards bodies accept that it is appropriate and it becomes EN ISO xxxxxx
• The national body then adopts the standard and it becomes (for example) BS EN ISO xxxxxx

There can be a time lag between the ISO issue and the EN / national body issue (generally due to voting and / or translation requirements) and hence the year of issue may be different. Occasionally an ISO may be 'adopted' and the year could be out by a couple.

Just to add a little more here to the already useful information:

There is no penalty as such, but in the extreme the Notified Body can cancel your certificate, at which point it would become illegal to sell CE marked devices. It is unlikely that an NB would go to such an extreme, but if there are repeated false claims this could be the case.

Although I do not condone it, manufacturers making false claims is actually very common from my experience as an auditor. The EU allows new standards to be introduced without any transition periods (e.g. EN 62304 for software life cycle), and these standard tend to be poorly implemented and also poorly checked by MDD auditors, and for good reason: logically there should be a transition period to give manufacturers time to prepare. There is often a unofficial transition period of 2-3 years before the ball starts rolling (e.g. auditors start to ask), and around 5 years before a standard is really implemented properly.

It is also worth to note that there is a statement in the "whereas" part of the MDD that says essential requirements and risk analysis are to be taken as being those at the "time of design", unless there is a serious safety concern. This means that new standards should really only be applied to new designs. But most NBs ignore this statement and expect that new standards are applied to old designs, which in turn can increase pressure to make false statements due to resource limitations.

Although these might be reasonable mitigating arguments for not applying a standard immediately, they are not really good excuses to make a false claim. Better just to document the real situation. If you think a standard is not important, or not worth to back date, say so and provide your alternate solution. Then it comes down to a technical disagreement not an outright falsification.

Peter Selvey said:

<snip> There is no penalty as such, but in the extreme the Notified Body can cancel your certificate, at which point it would become illegal to sell CE marked devices. It is unlikely that an NB would go to such an extreme, but if there are repeated false claims this could be the case. <snip>

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The penalties exist for any supplier of product into an EU Member State that does not meet the essential health & safety requirements called up in any directive and they are typically fines and / or imprisonment. The defendant could be the manufacturer or importer.

You are right that there is no specific penalty for not complying with a standard. Compliance with a European standard is normally used as a defence when a supplier is prosecuted under the legal requirement to supply safe product.

Is there any reference to a directive or other document that details these penalties? Sounds interesting.

Article 18 of the MDD only details that

Wrongly affixed CE marking
Without prejudice to Article 8:

(a) where a Member State establishes that the CE marking has been
affixed unduly or is missing in violation of the Directive, the manufacturer
or his authorised representative shall be obliged to end the
infringement under conditions imposed by the Member State;

(b) where non-compliance continues, the Member State must take all
appropriate measures to restrict or prohibit the placing on the
market of the product in question or to ensure that it is
withdrawn from the market, in accordance with the procedure in
Article 8.

Those provisions shall also apply where the CE marking has been
affixed in accordance with the procedures in this Directive, but inappropriately,
on products that are not covered by this Directive.

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the directive therefore leaves it up to each member state to define the consequences within their legal system

pkost is right the Directives are all implemented through National Legislation and Regulation. In the UK there is a useful site - here. The relevant paragraph explaining how the Directive is implemented in UK Law and the powers of the UK Regulator is available if you follow the link but I have copied a section here:

The Medical Devices Regulations are made under the Consumer Protection Act 1987 and the majority of the powers that can be used in carrying out the enforcement function are also derived from the Act. These include the power to inspect goods, enter premises, require records to be produced, seize and detain goods in order to find out if there has been a contravention of the safety regulations. Then if a contravention is found to issue notices suspending or prohibiting the supply of the product or as mentioned above if the manufacturer fails to bring the product into compliance voluntarily or adhere to formal enforcement measures to prosecute the offence. We also have additional powers for consumer products available direct to the public under the General Product Safety Regulations which include the power to require a manufacturer to recall faulty product. A successful prosecution under the Medical devices Regulations carries a maximum penalty of a £5,000 fine per offence or six months imprisonment and under the General Product Safety Regulations of a fine of £10,000 per offence or 12 months imprisonment.

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Powers are similar for most Directives. Hope this helps.