Regulatory Open Forum

Dear Fatemeh,
MDR, Art. 10 (9) requires a quality management system to "ensure that procedures are in place to keep series production in conformity with the requirements of this Regulation".
However, this means not that the QMS has to be certified.
Best regards - Sándor
p.s. please consider special rules for product registration in Italy

Fatemeh,

As stated the requirements in EU MDR 2017/745 there is a requirement to have a quality system, but it does not need to be certified to ISO 13485.  Some companies choose these for a variety of reasons including providing assurance to their customer they have a quality system in place.  But no, there is no requirement to be certified.  I often see self-declare companies of Class I devices have a "compliant" quality management system, but not spend the additional costs for actual certification.  Keep in mind also, ISO certification might be needed for other jurisdictions if selling outside of the European Union.

Dear Fatemeh,
MDR, Art. 10 (9) requires a quality management system to "ensure that procedures are in place to keep series production in conformity with the requirements of this Regulation".
However, this means not that the QMS has to be certified.
Best regards - Sándor
p.s. please consider special rules for product registration in Italy

Dear Fatemeh,
MDR, Art. 10 (9) requires a quality management system to "ensure that procedures are in place to keep series production in conformity with the requirements of this Regulation".
However, this means not that the QMS has to be certified.
Best regards - Sándor
p.s. please consider special rules for product registration in Italy

Hi Fatemah,

We found that customers would not except our product in many EU countries without a certified quality system.  Our AR required it.  It may not be literally stated, but be aware that most want to see the certificate.  You will also need to establish technical files for the various classifications of Class I devices that you are going to sell there.

Once completed you can sell into all of the countries in the EU and use those documents to leverage sales in the UK.  Most of what is required in the EU is now required in Switzerland (a third country) and the Middle East (ISO certification is a requirement) as well so it can potentially open new markets for you.

Unfortunately, the requirements have nothing to do with the size of the company.  We are small and have invested a very large amount of money to sell in the EU.  The amount of documentation required for a low risk medical device is essentially no different than a high risk one in the EU.

Good luck,

------------------------------
D Michelle Williams
VP - Operations
United States

Original Message:
Sent: 14-Jun-2023 14:29
From: fatemeh rahimi
Subject: Class I self certified device

Start with EU-MDR Article 52(7). You need a declaration of conformity, Annex II, and Annex III. They will lead you to Annex I and Article 10. Article 10 sets out what must be in your QMS. It does not require EN ISO 13485:2016/A11:2021.

By the time you are done, you will have implemented a lot of EN ISO 13485:2016/A11:2021. You could declare conformance to EN ISO 13485:2016/A11:2021. There is no requirement in this case to certification from an external body.

On the other hand, you may not need all of the those requirements to make good products.<o:p></o:p>