ISO 13485:2016, what about the MDR?

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Long awaited but finally there, and just in time before the end of the transition period of ISO 13485:2016, we have received our renewed QMS certificate! Again with the scope to design, develop, manufacture, distribute and service active medical devices, but now in compliance with the new version of the standard, well-prepared for the upcoming MDR transition. We are proud of such a big achievement!

As product safety and quality is of the utmost importance, it should not surprise you that every manufacturer, importer, distributor or other key player must establish and maintain a quality management system. Although not a ‘manufacturer’ in the sense of the MDR, Unitron still is a key player in the entire supply chain of a product, and therefore has a certified quality management system according to ISO 13485.

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If you could use any assistance in determining the specific QMS requirements for your business and your product, our Regulatory Affairs
support team is more than happy to help.
Please call (+31)(0)117 307 300 or send an
e-mail to regulatory@unitron.nl

QMS required by MDR

It may have occurred to you that being ISO 13485-certified takes care of compliance with all of the MDR requirements regarding Quality Management Systems (QMS). This  assumption is not entirely correct, however. First, the MDR text does not require ISO 13485 to be used for a company’s QMS: it only requires manufactures to have a QMS implemented and maintained. Second, when using this standard, the actual compliance with the MDR will depend on how you implement it within your company.

The international (worldwide) ISO standard is meant to be applicable within multiple jurisdictions, often having different or even opposing requirements for many aspects of a QMS. The only way to assure that the standard could be applied within a variety of legislative systems is to make it as little specific as possible: the so-called ‘holistic approach’ (concerning the whole rather than parts).

ISO 13485 contains high-level requirements for the QMS of organizations involved in the lifecycle of a medical device. Due to its international nature, it demands that the applicable regulatory requirements pertaining to the jurisdiction system under question are also taken into account. For the European Union, it is the MDR that contains these regulatory requirements, so both texts should be used simultaneously for upgrading your QMS to assure compliance with the new demands.

QMS requirements throughout the MDR

Article 10 of the MDR contains the ‘General obligations of manufacturers’. In subsection 9, this article lists the elements of the QMS a manufacturer should have in order to comply with the regulation. These are the ‘regulatory requirements’ referred to by ISO 13485. To facilitate a mapping between these requirements and the relevant normative clauses of the standard, Technical Report CEN/TR 17223:2018 can be helpful. The many QMS requirements can be found in various Articles and Annexes of the MDR, and they are called forth in Article 10. Here is a short list of the Articles and Annexes to find QMS requirements:

  • Annex I, Chapter 1 (Risk Management);
  • Annex IX (Conformity assessment based on a QMS system and on assessment of the technical documentation);
  • Annex XI (Conformity assessment based on product conformity verifications);
  • Article 61 and Annex XIV for Clinical evaluation, including post-market clinical follow-up (PMCF);
  • Annex II and III (Technical Documentation).

All of those aspects are ‘partially covered’ by EN ISO 13485:2016, as the standard requires the procedures to be present in the QMS, but for implementation other sources (such as EN ISO 14971:2012 for risk management and the MDR text) should be used.

How Unitron can help

If you have questions regarding how MDR would work for your product or QMS, or if you would like support in building your technical documentation and meeting MDR obligations, don’t hesitate to contact us.

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