Phil Johnson, Senior Principal, IQVIA Quality Compliance
Medical Device and In Vitro Diagnostics (IVD) manufacturers have been busy the last few years ensuring that their Quality Management System (QMS) met the requirements of ISO 13485:2016 and the Medical Device Single Audit Program (MDSAP). It was an interesting time as Notified Bodies (NB) and certification bodies also came up to speed on the new requirements and increased level of surveillance on manufacturers. MDSAP introduced new auditing concepts and non-conformance handling, and also introduced a new level of compliance to Quality systems, resulting in a more rounded system for addressing global regulatory needs.
As we paused for a breath in the MedTech industry, FDA then introduced a future revision of the federal regulation 21CFR Part 820 which will align more closely with ISO 13485:2016. The timeline for this revision has yet to be confirmed, but is expected to be introduced in the next 1-2 years. For manufacturers that are already certified to ISO 13485:2016, this revision to 21CFR Part 820 is not expected to cause too much concern. In advance of this revision, the Association for the Advancement of Medical Instrumentation (AAMI) has provided a good comparison of 21CFR Part 820 and ISO 13485:2016 in the guidance document (AAMITIR02 U.S. FDA 21CFR mapping to the applicable regulatory requirement references ISO 13485:2016 Quality Management Systems).
Risk-Based Approach to Quality Management
One of the major advances that was observed in the 2016 revision of ISO 13485 related to adopting a risk-based approach to all of the QMS processes. This approach is ahead of what is currently documented in 21CFR Part 820, although already in practice by most medical device manufacturers.
Prior to these developments, the next significant change to manufacturers’ QMS is bringing their systems in compliance to the EU MDR and EU IVDR requirements. The basis of the QMS is ISO 13485:2016 with additional changes required by EU MDR & EU IVDR. These needs are well known and have been extensively documented.
EU MDR: Are You Ready? Next Steps!
This webinar provides answers to help you succeed in this time of change.
Quality Plan Initiation
If you have short term plans to place product on the EU market under the EU MDR, then you should start the Quality Plan for updating your QMS, as soon as possible. Some of the more specific needs are related to Post Market Surveillance and may need some advance planning, specifically the need for Periodic Safety Update Reports (PSUR) and Post Market Planning (PMP).
Begin by doing a gap analysis of your current QMS and the EU MDR. The recently published guidance document (PD CEN/TR 17223:2018) is a good place to start and provides information on the relationship between ISO 13485:2016 and the EU MDR & EU IVDR. A good example is the need in the EU MDR for the “Person Responsible for Regulatory Compliance (PRRC)”, as this position is not specifically called out in ISO 13485:2016 and will need to be included in the manufacturer’s QMS to be compliant with the EU MDR (& EU IVDR).
IQVIA Quality Compliance consultants are prepared and available to support your organization in assessing its level of compliance with current regulations and preparedness for upcoming modifications to industry requirements.
To learn more about how you can prepare, we encourage you to contact us by clicking here.