A Journey Of A Thousand Regulations Starts With A Gap Assessment (Doesn’t It?)

For MDR or IVDR remediation, gap assessments are a difficult process and results in a body of work without making any progress on actual remediation.

Although gap assessments are an important tool to review gaps and provide evidence of compliance, the magnitude of the Medical Device Regulation (2017/745), multitude of MDCG documents interpreting the articles, and industry guides creates complexity to list and map out requirements.

Since 2020, I worked on several gap assessments as a first step for MDR (2017/745), including the following:

• Current state versus desired state.
• Comparing a list of requirement against existing evidence in procedures
• Excel based comparison between articles of a regulation against existing procedures

Regardless of the format, after going through the exercise the following became clearly evident:

• Many requirements in the existing QMS that were not met
• There was no way to prioritize improvements
• No clear way to demonstrate success or progress in a meaningful way

Quality Planning helps keep the ‘End in Mind’

Rather than starting with a gap assessment, we started with quality plans mapping out key end points and deliverables and phasing the quality system improvements in an organized manner.  What evidence can we provide to auditors to demonstrate compliance?

After working on creating the templates for deliverables and aligning quality system processes to provided the inputs needed for the templates we were able to make progress and immediately start providing evidence of remediation.

Gap Assessments After Remediation

Performing the gap assessment after remediation was much more efficient because the deliverable and evidence for improvement was already defined and we had working example to compare against requirements.

The 2020 gap assessment of MDR articles and annexes were never completed before the certification audits and it never mattered or came up during any meetings with auditors.

As the gap assessments didn’t help before or after certification, the lessons learned highlights the minimal practical value of the gap assessments.  Starting remediation of such a large scale with gap assessments is an endless journey without starting the road towards compliance.

K. Seiki