5 BOLD Predictions for Medical Device Quality in 2023

With the new year upon us, we asked our Founder/President, Kyle Rose, and our General Manager (Taiwan Branch), Andrew Wu, to peer into their respective crystal balls and give us five intrepid prognostications for medical device quality in 2023!

1. FDA will release a roadmap and timeline for QMSR

QMSR is an important initiative that eliminates the need for device manufacturers to maintain multiple quality systems by aligning the QSR with ISO 13485:2016. FDA is very likely to propose the changes to regulations and guidance documents that reference Part 820, such as the risk management activities. Based on the feedback solicited from the Device Good Manufacturing Practice Advisory Committee (DGMPAC), FDA might propose a longer transition period than the originally planned one-year transition period as implementation challenges were identified and shared by industry representatives.

2. Far more clarity on the MDR situation 

As the European Commission adopted a proposal on January 6th 2023 to delay the full implementation of MDR until the end of 2027, the industry awaits the ‘accelerated co-decision’ from the EU’s parliament and council. However, the proposal does not intend to alter the regulations or offer solutions to the main obstacles such as high costs and long wait times. Additional clarity regarding the MDR transition is likely needed for the industry to act accordingly. 

3. FDA to focus audits and regulatory correspondence on COVID diagnostics

As the public emergency period possibly wanes off in 2023, there is a very likelihood that FDA will look into the EUAs and enforcement policy devices issued in the past year or so. In 2022, the FDA proposed the ‘EUA and Enforcement Policy transition plan’ which aims to lay out the necessary steps for medical device manufacturers who hold EUAs or commercialize their device through enforcement policies to carry out orderly transition for device designation. Regulators would consider audits and correspondence with the FDA to supplement additional information of their device are both necessary. 

4. UKCA marking guidances and enforcement deadlines will be released 

We hypothesize that manufacturers will face a similar, difficult path to accessing UK approved bodies for UKCA marking as they face with EU notified bodies for CE marking.The MHRA will release key guidelines and concrete deadlines for enforcement, adding more applications and compliance checkpoints for manufacturers wanting to sell in the UK. Please refer to our blog post about capitalizing on the UKCA marking enforcement delay.

5. FDA will publish some sort of additional supplementary framework that aligns with the pre-certification program

In terms of regulating SaMD or digital health applications, FDA is likely to propose an additional supplementary regulation framework (to the established regulatory pathway) that accommodates faster cycles of innovation for medical device software. This supplementary regulation framework aims to streamline the review process which is established on top of the organizational appraisal designation. 

Stay tuned for a cordial invitation to a RookQS webinar later this month. If you have questions that won’t wait, we’re here whenever you need us!