Ask Jon Speer.

Hi Ong,

Interesting question as on the regulation it doesn’t say specifically that your Quality System should be certified but it only says that you need to have one. And usually a standard is not mandatory.

Personally I’ve never met a company that is receiving a CE mark in Europe without a Certified Quality System as ISO 13485 for example and the reason is simple. It’s easy for you to build a QMS out of a Standard because you just apply what is said. And it’s also easy for the notified body because they have just to check if what is said is applied.

If your product is class I (European Rules), it’s a self-certification. So this can be a case where no Certified QMS is possible. But I doubt it as when you register the product they are usually asking you also for the QMS certification document.

At the end it’s your Notified Body that will provide you the CE Mark, so would be interested to ask them if it’s possible. (Not if they recommend that to you)

So interesting case. I would really like to hear opinions of others.

I am as a actual manufacturer for Class I device (non measuring/non sterile) have not obtain ISO 13485. But yes to be in safer side included QMS system in manufacturing premise, but my legal manufacturer having ISO 13485:16.

Hi Monir,
I shared your doubtfulness as well. In my case, the CE mark is for a Class IIb device and yet it really baffles me when the legal manufacturer says they do not have ISO13485 certification.

In both the MDD and the new MDR, there is no requirement for certification. You can undergo annual QMS audits by a Notified Body to the MDD or the MDR. However, the audits cost the same amount and you don’t get the benefit of claiming certification for other countries that may require it. In the case of Class I, you could hire a NB to conduct a QMS audit without ISO 13485:2016 certification. I have never seen it done, but it is allowed. However, I think you may find that there are some countries in Europe and Authorized Reps that will not allow you to register your product in Europe without an ISO 13485 certificate. You can declare compliance with the directive, but they expect quality system certification.

There are different “Routes of assessment” that allow you to distribute your products in the EU. You can choose Annex II, “Full Quality Assurance” which most companies do. In the long run it is the best route. However, you can select other annexes as your route of assessment and get a “Type Examination (TE)” certificate specific to your device, route of assessment and not associated with your QMS certification. In either case, you still would need annual or bi-annual audits and dossier reviews to the appropriate MDD (MDR) to maintain your certificate. There are a number of routes of assessment to get your devices on the market.