Certified QMS for MDR - Class I medical device manufacturers

[JoCam]

Hi All,

I've read a lot of reports saying that class I medical device manufacturers do not need to have their Quality Management Systems certified to comply with the MDR. However, it is clearly stated in MDR Annex IX Chapter 1 section 2 that the QMS needs to be assessed by a Notified Body. Is this assessment something different to certification, is there something stated elsewhere in the MDR that exempts this requirement for class I devices, or are the reports I've read incorrect?

JoCam

 

[dgrainger]

I don't think you need to look at Annex IX unless Class Is, Ir or Im.:

Article 52 Conformity assessment procedures​

​

7.Manufacturers of class I devices, other than custom-made or investigational devices, shall declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 19 after drawing up the technical documentation set out in Annexes II and III. If those devices are placed on the market in sterile condition, have a measuring function or are reusable surgical instruments, the manufacturer shall apply the procedures set out in Chapters I and III of Annex IX, or in Part A of Annex XI. However, the involvement of the notified body in those procedures shall be limited: (a) in the case of devices placed on the market in sterile condition, to the aspects relating to establishing, securing and maintaining sterile conditions; (b) in the case of devices with a measuring function, to the aspects relating to the conformity of the devices with the metrological requirements; (c) in the case of reusable surgical instruments, to the aspects relating to the reuse of the device, in particular cleaning, disinfection, sterilization, maintenance and functional testing and the related instructions for use.​

 

[chris1price]

Yes, in most cases, the NB needs to assess the Quality Management System. The requirements for this QMS are described in Article 10, however this list is only a subset of ISO13485 requirements. There are other types of QMS that meet Article 10, for example one meeting 21CFR820, or a pharmaceutical quality system. For some companies, the additional burden of administering a certified ISO13485 system outweighs the benefits of being certified; so being assessed against Article 10 is the easier route.

 

[JoCam]

Yes, in most cases, the NB needs to assess the Quality Management System.

Hi Chris,

In which cases do the NB need to assess the Quality Management System? Is there ever a case where you are not required to have your QMS assessed by a Notified Body?

JoCam

 

[chris1price]

If you are certified to ISO13485, they should not need to assess the QMS as part of the CE certification. However, in my experience, some NBs will perform both ISO and CE certifications in the same visit. This makes it difficult to separate one from the other.

In one company, it was only when looking carefully at the invoicing, could I see that the morning was charged to ISO certification and the afternoon CE certification. It practice the two inspections were done together.

 

[Murni Ahmad]

Hi All,

I faced the same situation same as JoCam too.

We are the local representative for our manufacturer in EU, we based in ASIA.
Here, the ISO13485 certification is mandatory for local registration, but my manufacturer kept telling us their QMS already audited under the new MDR, hence they don't need ISO13485. They only need the CE certification. The product is Class IIb.

The issue is the CE only mentioned comply to Annex II which is Technical Documentation only.

And, through my reading, I found that for QMS there should be Annex IX too.

How can I ask this manufacturer to provide proof of their QMS? Can I ask them by right they should also be issued a CE on Annex IX?

Thank you.

Murni

 

[Sinus Tarsi]

Hi Mumi,
ISO 13485 is specific to medical devices QMS systems. Is the manufacturer a medical device company? They have to have some type of QMS Standard regardless of what they're manufacturing in addition to the MDR CE Cert.

 

[ca_moni]

Here, the ISO13485 certification is mandatory for local registration, but my manufacturer kept telling us their QMS already audited under the new MDR, hence they don't need ISO13485. They only need the CE certification. The product is Class IIb.

they only need the CE mark if they sell in Europe; if they sell outside the EU , they shall comply with the local regulatory requirements

The CE mark conformity assessment procedures do not make ISO13485 certification mandatory, just require a QMS assessment.
But ISO13485 was the harmonized standard for QMS under the MDD (that is, the standard that , when applied, guarantee an immediate compliance of the company QMS to the QMS requirements of the Directive) .
It will be the harmonized standard under MDR as soon as the first list will be published. It seem strange that a company having to comply with the QSM obligation stated in Annex II of MDD or art10 and Annex IX of MDR does not require a ISO13485 cert to its NB : they are quite all accredited for issuing such certificates, and usually the quotation is not high if performed in attachment to a CE certificate evaluation.

The issue is the CE only mentioned comply to Annex II which is Technical Documentation only.
And, through my reading, I found that for QMS there should be Annex IX too.

It may be that their CE certificate is still a QMS approval under Annex II of the MDD 93/42/EEC Directive (quality system approval- equivalent to Annex IX of MDR (EU)2017/745 regulation ) ; they are still valid until their expiration date as a transitory measure (see article 120(3) of MDR)

How can I ask this manufacturer to provide proof of their QMS? Can I ask them by right they should also be issued a CE on Annex IX?

CE on MDR Annex IX will be required after the expiring date of their cert under MDD Annex II. But you can tell them that in your country ISO13485 is required for the manufacturer and if want to sell there, they need to have it.

ca_moni

 

[ca_moni]

Hi Chris,

In which cases do the NB need to assess the Quality Management System? Is there ever a case where you are not required to have your QMS assessed by a Notified Body?

JoCam

as stated by DGrainger, If your company manufactures only class I non sterile, non measuring, non surgical reusable devices. for these low risk devices, compliance with MDR requirements (inclusing QMS) is self-declared.