Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello EU experts, 

I understand there are a variety of conformity assessment routes a manufacturer can choose from (e.g. full quality assurance, EC-type examination,EC-verification, production quality assurance). What are the advantages of each route? Why do most manufacturers choose the full quality assurance route?  Thanks. For startup companies with a QMS, do routes other than full quality assurance offer cost-saving advantages or any other advantages?  Thanks!

Hi Anon,

If your company has ISO 13485, the Notified Body can check only your technical documentation and skip the full QMS audit.
On the other hand, most of the NBs are also accreditation bodies for ISO 13485, so many companies choose a full QMS audit to receive also the ISO 13485 certification at the same time with the CE.

I hope my answer does not confuse you

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Spyros Drivelos
Medical Devices Manager
Agia Paraskevi, Athens
Greece
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Original Message:
Sent: 14-Jan-2019 22:40
From: Anonymous Member
Subject: EU Conformity Assessment Route

This message was posted by a user wishing to remain anonymous

Hello EU experts,

I understand there are a variety of conformity assessment routes a manufacturer can choose from (e.g. full quality assurance, EC-type examination,EC-verification, production quality assurance). What are the advantages of each route? Why do most manufacturers choose the full quality assurance route?  Thanks. For startup companies with a QMS, do routes other than full quality assurance offer cost-saving advantages or any other advantages?  Thanks!

This really depends on the device type and your responsibilities for design, manufacturing, testing, and distribution.  Many choose Annex II MDD (or in future Annex IX MDR) because they are achieving ISO 13485 which is a typically a full quality management system review.  The main difference is those choosing Annex V MDD (or in future Annex XI MDR) is they do not have responsibility for design control or design controls are not significant, i.e. a commonly produced Class IIa or Class I S/M/R device.  The other conformity assessment routes such as EC-Type examination are really specific for a device type.  Annex II (Annex IX for MDR) is just commonly used because many apply design controls, obtain ISO 13485 certification, and have their technical documentation file reviewed.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 16-Jan-2019 04:04
From: Spyros Drivelos
Subject: EU Conformity Assessment Route

Hi Anon,

If your company has ISO 13485, the Notified Body can check only your technical documentation and skip the full QMS audit.
On the other hand, most of the NBs are also accreditation bodies for ISO 13485, so many companies choose a full QMS audit to receive also the ISO 13485 certification at the same time with the CE.

I hope my answer does not confuse you

------------------------------
Spyros Drivelos
Medical Devices Manager
Agia Paraskevi, Athens
Greece

Original Message:
Sent: 14-Jan-2019 22:40
From: Anonymous Member
Subject: EU Conformity Assessment Route

This message was posted by a user wishing to remain anonymous

Hello EU experts,

I understand there are a variety of conformity assessment routes a manufacturer can choose from (e.g. full quality assurance, EC-type examination,EC-verification, production quality assurance). What are the advantages of each route? Why do most manufacturers choose the full quality assurance route?  Thanks. For startup companies with a QMS, do routes other than full quality assurance offer cost-saving advantages or any other advantages?  Thanks!

Good question. In my experience, most companies take the "full QS" route primarily because they need to have the full QS in place anyway for other markets and the additional hassle of the other routes isn't worth the business gain.

That said, I have occasionally used the EC-type examination route - generally for an acquired product from a company that did not have a mature QS. In these situations, if the technology is robust and compliant, this can be the faster route. Time to market was generally the advantage. It is expensive (or was comparatively the last time I did it) and requires ongoing maintenance that is more burdensome than the full QS route (think having to get your samples to them to test and get in the queue each time).

g-


------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN
------------------------------

Original Message:
Sent: 14-Jan-2019 22:40
From: Anonymous Member
Subject: EU Conformity Assessment Route

This message was posted by a user wishing to remain anonymous

Hello EU experts,

I understand there are a variety of conformity assessment routes a manufacturer can choose from (e.g. full quality assurance, EC-type examination,EC-verification, production quality assurance). What are the advantages of each route? Why do most manufacturers choose the full quality assurance route?  Thanks. For startup companies with a QMS, do routes other than full quality assurance offer cost-saving advantages or any other advantages?  Thanks!

Good question and good answers provided in this post but in absence of the device classification (i.e whether Class II or Class III device for choosing Annex II) weighing the options becomes somewhat vague. 

To recap, Article 11 of MDD allows the following options for CE Marking, based on the device classification from Annex IX:
CAP options -
EU Class: I  = Annex VII
EU Class: IIa) = Annex VII + IV or VII + V or VII + VI
EU Class: IIb) = Annex II (minus Sec. 4) or III + IV or III + V or III + VI
EU Class: III = Annex II or III + IV or III + V
 
In addition to the benefits of a full Quality System (ISO 13485 per Annex II) discussed in this post, the Notified Body's assessment of the technical documentation may drive organizations to choose alternative options.

The GMED / LNE website has a good article with a detailed table that succinctly explains the circumstance:
Understanding the Annexes for Medical Devices
https://lne-america.com/library/news/understanding-the-annexes-for-medical-devices

Hope this helps.
​

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Homi Dalal RAC
Regulatory Affairs Leader
Christchurch
New Zealand
------------------------------

Original Message:
Sent: 16-Jan-2019 10:34
From: Ginger Glaser
Subject: EU Conformity Assessment Route

Good question. In my experience, most companies take the "full QS" route primarily because they need to have the full QS in place anyway for other markets and the additional hassle of the other routes isn't worth the business gain.

That said, I have occasionally used the EC-type examination route - generally for an acquired product from a company that did not have a mature QS. In these situations, if the technology is robust and compliant, this can be the faster route. Time to market was generally the advantage. It is expensive (or was comparatively the last time I did it) and requires ongoing maintenance that is more burdensome than the full QS route (think having to get your samples to them to test and get in the queue each time).

g-


------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN

Original Message:
Sent: 14-Jan-2019 22:40
From: Anonymous Member
Subject: EU Conformity Assessment Route

This message was posted by a user wishing to remain anonymous

Hello EU experts,

I understand there are a variety of conformity assessment routes a manufacturer can choose from (e.g. full quality assurance, EC-type examination,EC-verification, production quality assurance). What are the advantages of each route? Why do most manufacturers choose the full quality assurance route?  Thanks. For startup companies with a QMS, do routes other than full quality assurance offer cost-saving advantages or any other advantages?  Thanks!