Developments in quality management systems for medical devices

Updates on the application and status of ISO 13485

AAMI, BSI and the US FDA hosted an international conference on standards and regulation of medical devices in Reston, Virginia in April 2019. One of the sessions at the conference focused on ISO 13485. The session addressed its use in the US regulatory scheme, the systematic review of the standard and its harmonization in Europe under the regulations for medical devices and IVDs.

The US FDA had previously announced its intention to replace certain aspects of the existing Quality System Regulation (QSR) with ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes. The revisions are intended to reduce burdens on manufacturers, particularly in compliance and record keeping, by harmonizing US and international requirements. The revisions will also modernize the regulation.The FDA intends to keep its inspectional authority and will continue to participate in MDSAP as a voluntary programme.  Work is underway to update the FDA auditing approach in the Quality System Inspection Technique (QSIT) and to plan to update the current cross-references to the QSR from other regulations. It was estimated that the draft of the wording of the regulation would be issued in late 2019 and that there was likely to be a transition period of several years.

A systematic review of ISO 13485 was started in April. This is undertaken by a ballot of the participating members of the Technical Committee responsible for the standard. The ballot period is 20 weeks. After the ballot, a decision is made on whether to confirm, revise or withdraw the standard. Informal discussions suggest that many participating countries favour a period of stability as the transition to the latest edition of the standard has just ended.

The European Commission has issued a draft request to the European Standards organizations for the preparation of standards to support the Medical Devices Regulation (MDR) and the IVD Regulation (IVDR). The EU Commission has, in conjunction with stakeholders, identified a number of horizontal standards as being key to implementation of the regulations and therefore a priority for harmonization. The European adoption of ISO 13485 is one of these high priority items with a deadline for adoption in May 2020. As a result, CEN has initiated the process to make an amendment to EN ISO 13485:2016. This amendment will only affect the European Foreword and the European Annexes Z. There will be no changes to the requirements in the standard itself. Two additional Annexes, designated ZD and ZE, will be added to the standard. These annexes map the relationships between the requirements of the MDR and IVDR respectively with the clauses in EN ISO 13485:2016. A European Technical report - CEN/TR 17232:2018 - Guidance on the relationship between EN ISO 13485: 2016 and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation – had previously been published with an initial mapping. This Technical Report forms the basis of the new Annexes for the amendment to EN ISO 13485:2016. An initial draft of the new European elements has been circulated and the comments received are in the process of being addressed. A revised version will then be prepared for ballot.

If you want to know more about this topic, it is on the agenda at the BSI & AAMI International Conference on Medical Device Standards and Regulations at the Sheraton Skyline Hotel Heathrow on 27-28 June 2019. Many other matters concerning regulations and standards for medical devices will also be covered.

Author: Eamonn Hoxey, of E V Hoxey Ltd, UK, is a writer, trainer and consultant on a range of life science areas including regulatory compliance, quality management, sterility assurance and standards development