Hi Ya'll!

First off let me start by saying "I LOVE this website!!". What a wealth of knowledge!

I need a reality check here. I have been informed by a collegue that they plan to CE Mark their class IIa device by complying with Annex V & VII, but without certifying to ISO 13485. Am I crazy, or isn't the requirement for Annex 5 to comply with 13485 (excluding Design)? Wouldn't that hence require cert to the standard? What is your take on this...

Hi Ya'll!

First off let me start by saying "I LOVE this website!!". What a wealth of knowledge!

I need a reality check here. I have been informed by a collegue that they plan to CE Mark their class IIa device by complying with Annex V & VII, but without certifying to ISO 13485. Am I crazy, or isn't the requirement for Annex 5 to comply with 13485 (excluding Design)? Wouldn't that hence require cert to the standard? What is your take on this...Hi Senna and welcome.

I don't believe he needs to register to ISO 13485. As far as I can tell, there is nothing in the Medical Device Directive that specifies a particular quality system standard. So it is possible to do what your collegue suggests, as long as his system meets the appropriate requirements of the MDD. All your collegue needs is a Notified Body to assess his system to the requirements of the MDD and the particular annex he choses, providing it is appropriate to his organization. The NB will issue an appropriate EC Certificate for ANNEX V, Production Quality Assurance. Your collegue's organization will then issue a Declaration of Conformity in accordance with Annex VII.

Thanks for your feedback. In the spirit of constructive banter, I wanted to reply to your email. I guess my confusion comes from the fact that in past experiences with CE Marking product (we used SGS out of the UK) we were required to certify to EN46000 (now ISO 13485) for annex V. I referred to the MHRA's guidance doc on conformance assessment procedures (Bulletin 4) and it states the following: "Class IIa - As for class I, the manufacturer declares conformity with the provisions of the Directive and Regulations and ensures that his products comply with relevant Essential Requirements.

However, for Class IIa products, this declaration must be backed up in all cases with conformity assessment by a Notified Body. This assessment may, at the manufacturer’s choice, consist of:

i. Examination and testing of each product or homogenous batch of products (Annex IV); or
ii. Audit of the production quality assurance system(Annex V:) ISO 13485:2003(excluding Design) or iii. Audit of final inspection and testing (Annex VI:) ISO 13485:2003 (excluding Design & Manufacture) or iv. Audit of the full quality assurance system (Annex II) ISO 13485:2003 Once the manufacturer has received certification from the Notified Body he may CE mark his products and place them on the market."

So based upon this information, I interpret this to mean that to meet Annex V, a certification audit to 13485 is a must. Am I missing something here? Could it be that different notified bodies require different things? (That would be most distressing from a regulatory standpoint!) What is your take on this?


Senna

So based upon this information, I interpret this to mean that to meet Annex V, a certification audit to 13485 is a must. Am I missing something here? Could it be that different notified bodies require different things? (That would be most distressing from a regulatory standpoint!) What is your take on this?SennaYes, different notoified bodies can require different things. Nowhere does the MDD or subsequent legislation require registration to ISO 13485. The ISO 13485 standard incorporates all the MDD requirements. If you can find a NB to do it, you can set-up a system that complies with the MDD and never mention ISO 13485. Look at your EC Certificate. For Annex V it will state:

EC CERTIFICATE

PRODUCTION QUALITY ASSURANCE SYSTEM APPROVAL CERTIFICATE

(Annex V of the Directive 93/42/EEC on Medical Devices)

We hereby declare that an examination has been carried out following the requirements of the national legislation to which the undersigned is subject, transposing annex V of the Directive 93/42/EEC on medical devices.
We certify that the production quality system conforms with the relevant provisions of the aforementioned legislation.

Where does it refer to ISO 13485?

Using 13485 is convenient for the NB, but not mandatory.

Does anyone else have a different opinion?

So based upon this information, I interpret this to mean that to meet Annex V, a certification audit to 13485 is a must. Am I missing something here? Could it be that different notified bodies require different things? (That would be most distressing from a regulatory standpoint!) What is your take on this? Senna
Yes, different NB's will require different things, since there is more than one way to demonstrate conformance to essential requirements.
Below are some excerpts from ANNEX V of the MDD
"...ANNEX V
EC DECLARATION OF CONFORMITY (Production quality assurance) 1. The manufacturer must ensure application of the quality system approved for the manufacture of the products concerned and carry out the final inspection, as specified in Section 3, and is subject to the Community surveillance referred to in Section 4.
2. The declaration of conformity is the part of the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned conform to the type described in the EC type-examination certificate and meets the provisions of this Directive which apply to them.
The manufacturer must affix the CE marking in accordance with Article 17 and draw up a written declaration of conformity. This declaration must cover a given number of identified specimens of the products manufactured and must be kept by the manufacturer.
3. Quality system
3.1. The manufacturer must lodge an application for assessment of his quality system with a notified body.
The application must include:
- the name and address of the manufacturer,
- all the relevant information on the product or product category covered by the procedure,
- a written declaration that no application has been lodged with any other notified body for the same products,
- the documentation on the quality system,
- an undertaking to fulfil the obligations imposed by the quality system is approved,
- an undertaking to maintain the practicability and effectiveness of the approved quality system,
- where appropriate, the technical documentation on the types approved and a copy of the EC type-examination certificates,
- an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:
(i) any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;
(ii) any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in subparagraph (i) above leading to a systematic recall of devices of the same type by the manufacturer.
3.2. Application of the quality system must ensure that the products conform to the type described in the EC type-examination certificate.
All the elements, requirements and provisions adopted by the manufacturer for his quality system must be documented in a systematic and orderly manner in the form of written policy statements and procedures. This quality system documentation must permit uniform interpretation of the quality policy and procedures such as quality programmes, plans, manuals and records.
It must include in particular an adequate description of:
(a) the manufacturer's quality objectives;
(b) the organization of the business and in particular:
- the organizational structures, the responsibilities of the managerial staff and their organizational authority where manufacture of the products is concerned,
- the methods of monitoring the efficient operation of the quality system and in particular its ability to achieve the desired quality of product, including control of products which fail to conform;
(c) the inspection and quality assurance techniques at the manufacturing stage and in particular:
- the processes and procedures which will be used, particularly as regards sterilization, purchasing and the relevant documents,
- the product identification procedures drawn up and kept up to date from drawings, specifications or other relevant documents at every stage of manufacture;
(d) the appropriate tests and trials to be carried out before, during and after manufacture, the frequency with which they will take place, and the test equipment used; it must be possible adequately to trace back the calibration of the test equipment.
3.3. 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 assessment team must include at least one member with past experience of assessments of the technology concerned. The assessment procedure must include an inspection on the manufacturer's premises and, in duly substantiated cases, on the premises of the manufacturer's suppliers to inspect the manufacturing processes.
The decision must be notified to the manufacturer after the final inspection and contain the conclusions of the inspection and a reasoned assessment.
3.4. The manufacturer must inform the notified body which approved the quality system of any plan for substantial changes to the quality system.
The notified body must assess the changes proposed and verify whether after these changes the quality system still meets the requirements referred to in Section 3.2.
After the abovementioned information has been received the decision is notified to the manufacturer. It must contain the conclusions of the inspection and a reasoned assessment.
4. Surveillance
4.1. The aim of surveillance is to ensure that the manufacturer duly fulfils the obligations imposed by the approved quality system.
4.2. The manufacturer authorizes the notified body to carry out all the necessary inspections and must supply it with all relevant information, in particular:
- the documentation on the quality system, ...."

The harmonized Standards for the MDD are available @ http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/reflist/meddevic.html

For QMS, the site states
CENEN ISO 13485:2000 Warning (http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/reflist/meddevic.html#warning)
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001:1994 (revision of EN 46001:1996) C 182 of 2002-07-31

Reference of the superseded standard: EN 46001
Date of cessation of presumption of conformity of the superseded standard: 2004-03-01 (Note 1 (http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/reflist/meddevic.html#note1))
CENEN ISO 13488:2000 Warning (http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/reflist/meddevic.html#warning)

Quality systems - Medical devices - Particular requirements for the application of ISO 9002:1994 (revision of EN 46002 :1996) C 182 of 2002-07-31

Reference of the superseded standard: EN 46002
Date of cessation of presumption of conformity of the superseded standard: 2004-03-01 (Note 1 (http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/reflist/meddevic.html#note1))
CENEN ISO 13485:2003 Medical devices - Quality management systems - Requirements regulatory purposes (ISO 13485:2003) C 83 of 2004-04-02
Warning :- EN ISO 13485:2003 replaces two earlier standards; EN ISO 13485:2000 and EN ISO 13488:2000.
- The earlier standards EN ISO 13485:2000 and EN ISO 13488:2000 will cease to provide presumption of conformity with relevant Essential Requirements on 31st July 2006 at the end of the agreed transition period.


So, certification to ISO 13485 is a natural and cost-effective way for the NB to verify and perform surveillance of the manufacturer's QMS, as mandated by the MDD. But, other arrangements could be deployed.

For IIa medical devices, it is rather a must to have 13485:2003 with or without design. In order to sell class II medical devices in Canada, the quality system of the manufacturer should be ISO 13485 compliant through a Health Canada recognized registrar.

It would be adviseable to have 13485:2003 to meet most of the requirements. It may otherwise be cumbersome to meet individual country requirements, if you want to export to other regions of the world.

Thanks everyone for the info! I guess the next time I am faced with CE Marking, the first question I will ask the Notififed Body is what their expectations are in regards to compliance with the MDD!

Regards to all,

Senna

Hi everyone,

I work in the Netherlands for a company that designs and builds equipment for the Nuclear Medicine.
Amongst these are some class IIa Medical devices (acc MDD rule 9 and 10).
We are ISO9001:2000 certified for development, production and sales of "all" our products.
For the CE marking of our medical devices we choose the following route:
EC Declaration of Conformity (Annex VII) combined with,
Production Quality Assurance (Annex V) (see quote at bottom*)

Just for the few MD's we are not ISO13485 certified!
We have a well documented QMS acc. ISO9001:2000 plus documented PMS, vigilance and technical documentation for each MD supported with (required) test reports acc. 60601-1 and 60601-1-2.
One MD is already CE (medical) approved but that was about 2-3 years ago.
I'm now working (since 1 year) to get 2 more approved using this same route.

We are up for inspection by our NB next month :whip: .

I'll let you know here what the outcome is:cfingers: .

As previously noticed by other covers, a QMS mandatory.
Though how you fulfill this requirement is up to you.
ISO13485 is recommended, but if you use ISO9001 with some additions might be just as good.
Is it possible to have all ISO13485 requirements in place and be not certified (by a third party)?
What matters most is that you can show you're in control I gues and fulfill the essential requirements. Standards show you a standard way to comply, but you can just as well use different methods.

Just my :2cents:
Any comments are more than welcome.

Regards,
Jerome

*Quote from the MDD:
Article 11
Conformity assessment procedures
2. In the case of devices falling within Class
IIa, other than devices which are custom-made or
intended for clinical investigations, the manufacturer
shall, in order to affix the CE marking, follow the
procedure relating to the EC declaration of
conformity set out in Annex VII. coupled with either:
(a) the procedure relating to the EC verification
set out in Annex IV;
or
(b) the procedure relating to the EC
declaration of conformity set out in Annex
V (production quality assurance);
or
(c), the procedure relating to the EC declaration
of conformity set out in Annex VI (product
quality assurance).
Instead of applying these procedures, the
manufacturer may also follow the procedure
referred to in paragraph 3 (a).
3. In the case of devices falling within Class
lIb, other than devices which are custom-made or
intended for clinical investigations, the manufacturer
shall, in order to affix the CE marking, either:
(a) follow the procedure relating to the EC
declaration of conformity set out in Annex
II (full quality assurance); in this case,
point 4 of Annex II is not applicable;

Thanks , its been very informative, it would be helpful if you could suggest a routemap for CE marking of Class11a device in europe

Here you go:

http://www.dgm-nb.org/veje_til_ce/ce_medicin.shtml

:bigwave:

Hi Senna,

I hope things are going well with SGS. Either way, please drop me a line, always good to talk to our clients!


Okay so let's confirm a few things.

First you do need a quality system if you are going to follow Annex V.
No, you don't need to have ISO13485:2003.

The example given above of the company that holds ISO9001 with lots of additional regulatory procedures shows how this can be managed.

But it is an uncommon approach, and not really one I would recommend (but not for the reason suggested that it is convenient for SGS!)

Firstly it is the appropriate harmonised standard, so you either need to have it, or something equally as good, or a damned good reason why not.

The thing is we will audit you as if you do have it (since it is the established tool we will be using to determine compliance), so if you don't want to be certified you still have to go through plenty of effort to check you haven't missed anything.

And of course if you do opt for ISO13485 you will also end up with a shiny certificate on the wall, which is often important for commercial status reasons.

(Finally my organisation basically doesn't charge extra for issuing ISO9001, ISO13485 and MDD certs. Our view is that it is one audit, one cost. Clients tend to love that, as they can add ISO13485 for free, as they will be paying for ISO9001 and MDD anyway).


On top of ISO13485, your quality system will need to include procedures that cover the specific requirements of the MDD listed in:
a) the Articles
b) any Annex that may apply (I, V, VII, IX, X, XII)

(N.B. Demonstrating full compliance to the US FDA QSR gets you close, but not close enough, plenty of docs on the Cove comparing the two).


Next - you are right, don't need design control. You can formally exclude it from your quality system. Even if you have a huge R&D department that spends all day designing new versions of your Class IIa device. How cool is that?!
The reason is that 7.3 can be excluded if the regulations permit it. Only if you follow Annex II do you need to demonstrate design control, thus under Annex V you can legally exclude it - even if you do control design.


In reality I would really recommend that you do indeed include design as fully as possible (which may lead you to consider applying for Annex II).

Apart from subcontract manufacturers that just build to defined specifications, pretty much every company does some level of design, even if it is limited to change control, the odd tweak to the product or manufacturing process here and there. So if you do it, you might as well control it effectively under the established QMS, if you do it well you can improve efficiency.

But where having established design control process really comes into its own is when you suddenly find yourself designing a new product. It's not a great time to have to start building a design QMS from scratch.

Worse, is when you get near to the end of the design process and you find that you cannot demonstrate good design control (poor records, incomplete evidence of design validation etc etc).


"But we only make Class IIa devices."

Sure - but business models change, local regulatory classifications change, and target markets change (regulatory classifications may be different where you intend to sell).

(Most of our clients actually apply for Annex II, even for Class IIa devices, and with the revision allowing Annex II for Class Im / Class Is devices, I would expect Annex V to head towards extinction).


Hope this was useful!