IVDR Transition Series – Episode 3

Stephen Quinn continues his IVDR transition Blog series and extolls the virtues of Gap Assessments when embarking on regulatory transitions. Read on to learn how this crucial business tool could be the difference between a successful transition or falling at the final fence.

Performing Gap Assessments

In my last blog on ‘IVDR Transition Planning’, I briefly touched upon the concept of the Gap Assessment and how important this process is for any organisation undergoing a significant and complex change, such as a shift in regulatory requirements. Having participated in a number of IVDR transition projects already, I cannot stress enough how crucial this step is in identifying deficiencies in current documentation, data and processes.

Objectives of the Assessment

A gap analysis is a process which compares the status of the current situation, with what is the target or expected scenario. In the context of IVD industry, this method provides a tool to identify sub-optimal or missing processes, capabilities or technical documentation. It also provides an opportunity to recommend steps that will remediate the revealed ‘gaps’ to help the organisation achieve its goal (in this case a successful transition to IVDR ).

By reviewing in this manner, manufacturers of IVDs can determine what they need to work on, to achieve the desired results or expectations of a new standard or to meet new regulatory requirements. They can also use the output information strategically, so that any remediation work is allocated to the correct personnel and that it is prioritised accordingly.

The Approach

Everybody who attempts a gap analysis task will do it slightly differently, but the principles of the overall intention are the same. For instance, you could be reviewing your current QMS to determine the gaps between it as it stands, with what is required for IVDR,

I would strongly recommend using the well tried and tested tabular method – as simple as utilising a spreadsheet. This makes sense, because a gap assessment, at its essence, is a side-by side comparison of two states – so visually and practically, a table on a spreadsheet is a very effective method of summarising both requirements and findings clearly and concisely.

The following is a simplified example of how the results of a gap assessment might be constructed in a table; driving data from left to right. This is important, as the gap assessment itself, is just one step on the path of the transition process, and as demonstrated below, may then be extended to plan, execute and verify further remediation tasks.

In the context of transitioning to the IVDR;

• focus area would be a reference to a particular article or annex
• desired future state would be a description of the specific IVDR requirement
• current state would be evident by the pre-existing processes and technical documentation
• gap identified would list the evidence of the gap, i.e., findings, comments, references to procedures etc.

Best use of Output

As I mentioned earlier, the constructed table can be smartly adapted or continued in the left to right approach manner, to document what the organisation intends to do with the output of the gap assessment. This depends on the nature of the original task in hand but may include:

• Recommended or agreed actions
• Assigned responsibilities (e.g., department or personnel)
• Indication of priority e.g., high, medium, low)
• Start and end dates
• Current status (e.g., % completion)
• Verification of effectiveness (evidence confirming gap is closed out).

So, everyone is aware of the gaps, what needs to be done to fulfil them, who is responsible, how far they’ve got and when it must be completed by. If the table is updated accurately and effectively, the manufacturer has a clear understanding of the tasks necessary for successful transition and can monitor progress.

In summary:

Hopefully, having outlined the importance and benefits of using a gap assessment process for your transition, I’ve also provided some tips on how to set this this up, which will assist your organisation to meet its IVDR objectives.

Used well, this comprehensive tool will identify strengths and weakness, prioritise remediation work and drive allocation of time and resource required to tick tasks off.

How can IMed help?

IMed has a team of IVD experts on hand, who are well-versed with IVDR and completing transitions; including critical Gap Assessments, to set you on the right track. Just give us a call now on 01295 722800 or email us at hello@imedconsultancy.com