CE Mark Myths - The Medical Device Directive's Seven Major Myths

[Marc]

From Quality Digest:

The Medical Device Directive's Seven Major Myths

Mystified by the European Union's Medical Device Directive? The following seven points touch on some of the directive's persistent myths and how it will affect manufacturers:

Myth No. 1: CE marking is a trade barrier. Fact: The European Union views the CE Mark much like a passport. It is a manufacturer's claim that its product meets all applicable directives in force at that time. Member states must allow CE-marked products free market access.

Myth No. 2: The June 14, 1998, deadline was extended. Fact: There was no extension, and the current deadline was enforced.

Myth No. 3: All products placed on the market prior to the June 14, 1998, deadline will be exempt from CE marking until 2001. Fact: This is still only a proposal. Even if it is accepted, companies are finding sales negatively affected by the CE Mark's absence.

Myth No. 4: Countries in the EU can impose additional requirements within the directive. Fact: Countries must give products legally displaying the CE Mark free access to their markets. Member states may only restrict products that endanger the public.

Myth No. 5: ISO 9000 is sufficient to meet the directive's Annex II. Fact: In essence, EN 46001 is ISO 9001 plus specific medical requirements. Those additional quality items are found in EN 46001 and Annex II.

Myth No. 6: A manufacturer needs only a Declaration of Conformity for Class I Devices. Fact: Items required by the MDD's Annex VII include the technical file, post-market vigilance, risk analysis, and essential requirements for health and safety.

Myth No. 7: All 15 recognized European languages must appear on a product's label to meet EU standards. Fact: It depends on what the product is and where it is sold. Some member countries require their languages on the labels of any products marketed within their borders. The audience the product is meant for also must be considered.

For more information, call the MDD Hot Line at telephone (800) 810-9000.

(Excerpted from European Community Quarterly Review, Volume VI, Issue 2, Technology International Inc., 1998.)

 

[barb butrym]

Nice Post...once again lets hear it for Marc !!!!!!

 

[Don Winton]

Agreed, good post. I would like to add another common one (or at least one I have encountered often).

To obtain a CE Mark for a medical device, your firm must be audited by a notified body. This is not true. That varies with the device and class.

Best Regards,
Don

 

[Marc]

To obtain a CE Mark for a medical device, your firm must be audited by a notified body. This is not true. That varies with the device and class.

Is this still true? Can anyone explain or expand upon this?

 

[Al Rosen]

Is this still true? Can anyone explain or expand upon this?

I believe non sterilized class I devices do not require a notified body. (I know that's a short answer, but it's all I have time for right now.)

 

[Roland Cooke]

Wonderful article, even though it is is seriously old, it is still mostly valid. I've added some of my own thoughts here.


Myth No. 1: CE marking is a trade barrier. Fact: The European Union views the CE Mark much like a passport. It is a manufacturer's claim that its product meets all applicable directives in force at that time. Member states must allow CE-marked products free market access.

Mostly true. Each country has the right to invoke the safeguard clause for any device they don't like. There's a few other wierd exceptions as well.

Myth No. 2: The June 14, 1998, deadline was extended. Fact: There was no extension, and the current deadline was enforced.

Oh so true, and may be true once more for 2005/50 (reclassification of hip/knee and shoulder implants) when the deadline for that is reached.

Myth No. 3: All products placed on the market prior to the June 14, 1998, deadline will be exempt from CE marking until 2001. Fact: This is still only a proposal. Even if it is accepted, companies are finding sales negatively affected by the CE Mark's absence.

It was an exciting time. :mg:
CE Marking was accepted very fast, and many companies that were "in the right" from a regulatory perspective, nevertheless got totally hammered by their customers who only wanted CE marked product.

Myth No. 4: Countries in the EU can impose additional requirements within the directive. Fact: Countries must give products legally displaying the CE Mark free access to their markets. Member states may only restrict products that endanger the public.

Mostly true - however many countries bolted on all sorts of interesting "local colour", when the Directive got transposed into their individual national legislations. Usually only us geeks need to worry about the differences, but every now and again...
There is talk that future versions of the European regulations will not be in the same Directive format, to avoid this very thing - one set of fixed rules for all.

Myth No. 5: ISO 9000 is sufficient to meet the directive's Annex II. Fact: In essence, EN 46001 is ISO 9001 plus specific medical requirements. Those additional quality items are found in EN 46001 and Annex II.

Mostly true - for some (very few) companies ISO9001 may be accepted, or perhaps a system that met the QSR. The European regulatory procedures etc are non-negotiable

Myth No. 6: A manufacturer needs only a Declaration of Conformity for Class I Devices. Fact: Items required by the MDD's Annex VII include the technical file, post-market vigilance, risk analysis, and essential requirements for health and safety.

Still true. Note of course that there are additional requirements if the Class I device is sterile or has a measuring function (or both).

Myth No. 7: All 15 recognized European languages must appear on a product's label to meet EU standards. Fact: It depends on what the product is and where it is sold. Some member countries require their languages on the labels of any products marketed within their borders. The audience the product is meant for also must be considered.

Still true, though I think the number of possible languages is approaching 20... :mg:


To answer Al's question, for "straight" Class I devices not only do you not need a Notified Body, you don't even need a quality system!
Annex VII has no such requirement, except for devices that are either sterile or have a measuring function in which case Annex V must also be followed. (The new revision of the MDD will allow Annex II also, a well-intentioned goof is why this is not an option currently).

Of course implementing a ISO13485:2003 system is recommended.


To go a little further, devices for clinical investigation, and custom-made medical devices, are outside the usual system and do not need Notified Body intervention. (Annex VIII).

Article 12 is a bit of a nightmare, but you could also potentially create a procedure pack or system without a Notified Body being involved.

 

[Wes Bucey]

In regard to medical devices - sometimes governments may have a different idea which class a product fits in than what the manufacturer thinks or uses in marketing. In such cases, governments willingly throw previously "grandfathered" products into the pool, requiring 3rd party certification to ISO13485 before allowing sale of previously allowed products.

The fairness of such a procedure is easy to visulaize if you consider whether the original formula for Coca Cola (with real cocaine) should be continued for sale merely because it was once allowed 100 years ago. (Or whether some of the machines in the Quack Medicine museum should be allowed to be sold because they were once allowed.)

 

[Roland Cooke]

Hi Wes, good points.

One of the big developments within Europe at the moment is the introduction of Directive 2005/50, making hip, knee and shoulder joint replacement implants highest-risk (Class III, from medium-high risk IIb). That has been done precisely because the grandfather products are seen by the authorities as NOT being adequately trustworthy.



A pseudo-myth related to your post above is that because a device has US FDA 510(k) approval it will automatically be accepted for EC certification.

These things tend to vary from one Notified Body to another, but essentially grandfathering, unsupported statements of equivalency, or approvals from countries outside the EU won't be blindly accepted.

Each device should stand on its own merits, in terms of evidence for safety, performance, and clinical benefit.

Of course for most descendant or copycat products, there IS data available to make those justifications possible - either already held by the applicant, or within the public domain. (Of course that's not the automatically the same thing as the data being presented clearly within the technical file! )

 

[wrodnigg]

>To obtain a CE Mark for a medical device, your firm must be audited by a notified body. This is not true. That varies with the device and class.
Is this still true? Can anyone explain or expand upon this?

Still true: Even with a Class III product, you do not need a quality management system which is audited by a notified body: you can conduct an EC type examination followed by EC verification (verification by examination and testing of every product or statistical verification).

It depends on the conformity procedure chosen by the manufacturer (Annex II ... Annex VII) - and not all procedures are allowed for all devices.

Myth No. 1: CE marking is a trade barrier. Fact: The European Union views the CE Mark much like a passport. It is a manufacturer's claim that its product meets all applicable directives in force at that time. Member states must allow CE-marked products free market access.

More or less - many other countries have established trade barriers. Look at the CMDCAS procedure, or the emerging national registration procedures in far east...

Myth No. 4: Countries in the EU can impose additional requirements within the directive. Fact: Countries must give products legally displaying the CE Mark free access to their markets. Member states may only restrict products that endanger the public.

As Wes wrote above: some countries have different ideas on classification of devices and on borderline products (medical/medicinal)

Myth No. 5: ISO 9000 is sufficient to meet the directive's Annex II. Fact: In essence, EN 46001 is ISO 9001 plus specific medical requirements. Those additional quality items are found in EN 46001 and Annex II.

Now we have EN ISO 13485:2003 for quality management and ISO TR 14969 as a guideline for this topic.
EN 46003:1999 is still a harmonized standard (containing references to EN ISO 9003:1994), since there is no follow-up standard like EN ISO 13485 for Product quality assurance (Annex VI MDD).

There is no specific requirement for a quality system, but there are specific requirements for some "systematic procedure" specified in Annex VII MDD.

Myth No. 6: A manufacturer needs only a Declaration of Conformity for Class I Devices. Fact: Items required by the MDD's Annex VII include the technical file, post-market vigilance, risk analysis, and essential requirements for health and safety.

Since the European Commission has admonished the member state to extend vigilance activities, systematic inspections at Class I device manufacturers have begun (Scope: Annex VII MDD).

Myth No. 7: All 15 recognized European languages must appear on a product's label to meet EU standards. Fact: It depends on what the product is and where it is sold. Some member countries require their languages on the labels of any products marketed within their borders. The audience the product is meant for also must be considered.

We have 20 languages at the moment (presumably 22 from 2007 on, if Romania and Bulgaria join the EU). For professional use english may be sufficient, but this has to be regulated in national law.