Medical devices – Quality management systems – Requirements for regulatory purposes

The release of the 2021 Amendment of ISO 13485:2016 has created a lot of curiosity amongst medical device organizations and quality professionals. 

The question which most of us have is: “What is new in the 2021 amendment of ISO 13485 standard?” Do not worry! We have the answers for that! 

This article focuses on the 2021 amendment of the ISO 13485 standard released by the British Standards Institute (BSI). In a nutshell, the amendment aims to align the ISO 13485 requirements for medical devices and in-vitro diagnostic devices with the EU MDR 2017/745 and EU IVDR 2017/746 Quality Management System criteria. As we know the EU MDR regulation has already been into effect from May 26, 2021, and the EU IVDR regulation shall be coming into effect from May 2022, hence this standard shall be beneficial for manufacturers in updating their documents and aligning with the additional QMS requirements as per MDR 2017/745 and IVDR 2017/746.

What has changed in ISO 13485:2016/A11:2021?

The amendment introduces the following Annexures under the existing standard:

  1. Annex ZA: This Annexure lists down the additional QMS requirements for medical devices as per MDR 2017/745 when compared with ISO 13485:2016.
  2. Annex ZB: This annexure details the additional QMS requirements for in-vitro diagnostic devices as per IVDR 2017/746 when compared with ISO 13485:2016. 

How does this standard apply to you as a manufacturer? Do manufacturers with MDD compliance need to comply with ISO 13485:2016/A11:2021?

Although medical device companies who are already in compliance with the ISO 13485:2016 and have their Quality Management well established are considering the additional requirements stated in the MDR 2017/745 regulation or IVDR 2017/746 regulation pertaining to regulatory requirements, however, to be in compliance with the MDR or IVDR requirements (from a quality perspective), especially for the items that are not covered or are partially covered under ISO 13485: 2016, this standard can guide the manufactures to keep a track of the gaps and start updating their documents to allow for a smooth transition from MDD to MDR or IVDD to IVDR.

Which SOP shall be updated as a part of MDR/IVDR remediation moving forward?

Here, we have given a list of SOPs that will need to be updated as a part of MDR/IVDR remediation to cover all the regulatory requirements. Please note the list is dynamic and may change based on manufacturers’ requirements:

  1. Control of Documents and Records SOP
  2. Management Responsibility SOP
  3. Labeling SOP
  4. Identification and Traceability SOP
  5. Risk Management SOP
  6. Analysis of data SOP
  7. Vigilance SOP
  8. Post Market Surveillance SOP
  9. Regulatory Strategy SOP

Is the ISO 13485:2016/A11:2021 standard harmonized by the European Union?

Yes, as per the latest guidelines issued by the European Union, the ISO 13485:2016/ A11:2021 standard was included in the list of harmonized standards for Medical Devices as per MDR 2017/745 dated 4 Jan 2022 and In-vitro Diagnostic Devices as per IVDR 2017/746 dated 6 Jan 2022. This means that manufacturers of Medical Devices and In-vitro Diagnostic Devices can include this standard and align their QMS with the specific requirements pertaining to MDR and IVDR regulations.

Which Articles/Annexes of MDR 2017/745 and IVDR 2017/746 are related to the Manufacturer’s Quality Management System Requirements?

Articles/Annexes of MDR 2017/745:

  1. Article 10 “General Obligations of the Manufacturer”.
  2. Annex IX “Conformity Assessment based on the assessment of Quality Management System and Technical Documentation”.
  3. Annex XI “ Conformity Assessment based on Product Quality Assurance”.

Articles/Annexes of IVDR 2017/746 :

  1. Article 10 “General Obligations of the Manufacturer”.
  2. Annex IX “Conformity Assessment based on the assessment of Quality Management System and Technical Documentation”.
  3. Annex XI “ Conformity Assessment based on Product Conformity Verification”.

The MDR 2017/745 or IVDR 2017/746 Regulations are big on clinical.

Some of the key requirements for the MDR 2017/745 and IVDR 2017/746  are in the clinical area. Some of these are as follows: 

  1. Extensive focus on Clinical Evaluation and Clinical Investigation (See Article 62-80 of MDR 2017/745) for showing compliance with General Safety and Performance Requirements stated in Annex I of MDR 2017/745. Similarly for IVDs, detailed requirements for clinical evidence, performance evaluation, and performance studies as per Chapter VI and Annex XIII of IVDR 2017/746.
  2. Post Market Clinical Follow-up (PMCF) declared as a mandatory requirement as per Article 10 (3) of MDR 2017/745 and Post Market Performance Follow-up (PMPF) declared as a mandatory requirement as per Article 10(3) IVDR 2017/746. However, this does not mean that the manufacturer has to do a PMCF study or a Post Market Clinical Investigation, as there are ways in which applicability is to be assessed. MDR 2017/745 Annex XIV Part B section 6.2 (b)  states various methods for conducting a PMCF of which PMCF study is one. 
  3. Stringent Post Market Surveillance activities as mentioned in Article 83 of MDR 2017/745 and Article 78 of IVDR 2017/746 and the enhanced timeline for reporting Recall as a part of Vigilance.
  4. Comprehensive Technical Documentation as per Annex II of the MDR 2017/745 and IVDR 2017/746 as compared to MDD 93/42/EEC and IVDD 98/79/EC.

Concerned about showing compliance with the regulatory requirements as per MDR/IVDR?

Wish to know more about this amendment and how it can support a transition to IVDR and/or MDR? Elexes is here to help you. Our dedicated team has rich experience performing updates on documents to meet the regulatory requirements as per EU MDR and EU IVDR. Please contact us via email at or call +1 650-503-6615 for further details.

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Blog ISO 13485

Elexes Team

Elexes medical consulting is one of the leading regulatory & compliance consultant for several industries: Medical device, Pharmaceuticals, Cosmetics, Food, and Biologics.

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