MDD confomity assessment - ISO 13485 registration counts for nothing???
We were audited and certified to the 13485:2003 standard last fall. We wish to CE mark our products (Class IIa) and need to have a conformity assessment performed by a NB (Annex V & VII). I was surprized that the NB said they needed to perform a physical audit at our facility, since the laungauge in the MDD indicates that:
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.
To me, this indicates that our ISO 13485 certification combined with a paper review of other technical documentation, labeling, etc., should be sufficient. I raised this question and they insist that they must physically come to audit our system as it applies to the MDD. They did indicate that the 13485 registration abbreviates the process significantly.
Re: MDD confomity assessment - ISO 13485 registration counts for nothing???
Quote:
Originally Posted by lifebreath
We were audited and certified to the 13485:2003 standard last fall. We wish to CE mark our products (Class IIa) and need to have a conformity assessment performed by a NB (Annex V & VII). I was surprized that the NB said they needed to perform a physical audit at our facility, since the laungauge in the MDD indicates that:
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.
To me, this indicates that our ISO 13485 certification combined with a paper review of other technical documentation, labeling, etc., should be sufficient. I raised this question and they insist that they must physically come to audit our system as it applies to the MDD. They did indicate that the 13485 registration abbreviates the process significantly.
What are your thoughts???
Are you using the same group that did your 13485:2003 audit to do you CE marking?
Re: MDD confomity assessment - ISO 13485 registration counts for nothing???
Quote:
Originally Posted by lifebreath
We were audited and certified to the 13485:2003 standard last fall. We wish to CE mark our products (Class IIa) and need to have a conformity assessment performed by a NB (Annex V & VII). I was surprized that the NB said they needed to perform a physical audit at our facility, since the laungauge in the MDD indicates that:
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.
To me, this indicates that our ISO 13485 certification combined with a paper review of other technical documentation, labeling, etc., should be sufficient. I raised this question and they insist that they must physically come to audit our system as it applies to the MDD. They did indicate that the 13485 registration abbreviates the process significantly.
What are your thoughts???
It's right there. The requirement is that the NB must do the audit. Since ISO 14485 is harmonized it is easier. I have always stated that the first thing to do when seeking to market a device in the EU is find a Notified Body. Who did your registration, maybe they have an association with a NB. I've attached the list of Medical Device Notified Bodies.
Re: MDD confomity assessment - ISO 13485 registration counts for nothing???
Our 13485 registrar is a well-known company, lets call them Reg Labs USA, that is affiliated with a NB, call them Reg Labs Services, based in Europe. They are both part of the same company group, Reg Labs Group.
The same company, Reg Labs USA (and even the same auditor) that did the 13485 audit will be doing the MDD audit on behalf of Reg Labs Services, the NB. Reg Labs Services will ultimately issue the certificate of conformity.
The NB's USA affiliate did the original 13485 audit, which included on-site inspection, and issued the 13485:2003 registration. This harmonized standard addresses all the requirements of the MDD pertaining to the quality system. They've already been here and determined our quality system complies with the harmonized standard. Why another trip needed?
Re: MDD confomity assessment - ISO 13485 registration counts for nothing???
Quote:
Originally Posted by lifebreath
Our 13485 registrar is a well-known company, lets call them Reg Labs USA, that is affiliated with a NB, call them Reg Labs Services, based in Europe. They are both part of the same company group, Reg Labs Group.
The same company, Reg Labs USA (and even the same auditor) that did the 13485 audit will be doing the MDD audit on behalf of Reg Labs Services, the NB. Reg Labs Services will ultimately issue the certificate of conformity.
The NB's USA affiliate did the original 13485 audit, which included on-site inspection, and issued the 13485:2003 registration. This harmonized standard addresses all the requirements of the MDD pertaining to the quality system. They've already been here and determined our quality system complies with the harmonized standard. Why another trip needed?
I don't think that's proper. I would be looking for a new Registrar. If you have to have a reassessment find an honest NB & Registrar. Just my
Re: MDD confomity assessment - ISO 13485 registration counts for nothing???
Whilst I agree that 2 visits is not idea, most NBs do officially make it two separate visits, even if one is in the morning and one in the afternoon. Compliance with 13485 is only one part of compliance with the Essential Requirements and other aspects of the MDD. I would assume that it is these aspects that will be audited in the second visit.
Re: MDD confomity assessment - ISO 13485 registration counts for nothing???
We always perform 13485 and MDD/IVD audits at the same time.
It makes no sense to distinguish between the two.
I had some cases, where I performed a full MDD audit (based on 13485), although the company had a 13485 certificate, but the certificate was not performed by a notified body. OTOH we recognize 13485 certificates issued by other notified bodies.
The scope of EN ISO 13485 certificates is often much broader, than the scope of a MDD certificate we issue.
lifebreath, could you wait to your next surveillance audit? In this case you could manage everything within one audit.
If your certification/notidies body does not agree to such a solution, I also would recommend to change one or both of them.
(I also know a customer, which had one C/NB for ISO 9001, one for 13485/MDD and a third one for CMDCAS)
MDD confomity assessment - ISO 13485 registration counts for nothing???
Re: MDD confomity assessment - ISO 13485 registration counts for nothing???
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