A summary of MDR Gap Analysis
An MDR Gap Analysis enables optimal allocation of resources & targeted evidence generation
What is an MDR Gap Analysis?
An MDR Gap Analysis is the process of systematically examining a medical device’s regulatory strategy and documentation against a detailed list of requirements. Any areas of non-conformity – or gaps – are then identified and can be corrected before definitive submission. Gap Analysis is a crucial step in developing and maintaining an MDR compliance strategy.
A Gap Analysis should be conducted according to a well organised and logical process. Because there are so many aspects to a successful MDR submission, it makes sense to organise the analysis around ‘themes’ or major areas, within which a more granular (line-by-line) analysis can be conducted.
Setting out requirements in advance helps to ensure that the Gap Analysis is conducted objectively. It also makes the process more efficient, operating like a ‘checklist’ to identify areas requiring an investment of time and attention.
What are the main considerations for an MDR Gap Analysis?
- General / administrative obligations
- GSPR analysis and resulting requirements
- MDR Annex II technical documents
- MDR Annex III documents – Post-Market Surveillance
- Risk Management File / requirements according to ISO 14971:2019
- Post-Market Clinical Follow-up – MDR Annex XIV Part B
- Sufficiency of clinical evidence against intended purpose and safety & performance objectives
- Clinical Evaluation – MDR Article 61 and Annex XIV Part A
- Quality Management System – MDR Article 10, ISO 13485:2016
- Person Responsible for Regulatory Compliance (PRRC)
- Summary of Safety and Clinical Performance (SSCP) – if relevant
- Additional documents in specific cases – for example, devices incorporating a medicinal product with an ancillary action.
Within each of these major areas, the analysis should be granular, considering sub-sections to ensure complete alignment with requirements. For example, the requirement for a Risk Management File could be further broken down into the components required by ISO 14971:2019:
- Overall Policy for Risk Acceptability
- Criteria for Risk Acceptability
- Risk Management Plan
- Intended use & reasonably foreseeable misuse
- Characteristics related to safety
- Preliminary Hazards Analysis
- Risk Evaluation
- Risk Control
- Risk Management Review
A detailed Gap Analysis would then set out detailed criteria within each of the above, enabling a line-by-line comparison of a device’s technical file against requirements for MDR compliance.
Gap Analysis for legacy devices
While vital for new devices, performing an Gap Analysis is also valuable in the case of legacy devices undergoing transition from the Medical Device Directive MDD 93/42/EC to the Medical Device Regulation (EU) 2017/745. Differences between the two pieces of legislation mean that technical files compliant with MDD may no longer be sufficient to meet the requirements of MDR.
Where can I get help in conducting a Gap Analysis?
Building the checklist required for a detailed Gap Analysis can be a daunting task.
Mantra Systems offers a free MDR Checklist covering the major elements of an MDR submission described above. It’s the ideal starting point for your MDR Gap Analysis.
We also offer a detailed pre-submission review of technical files against MDR requirements, helping to save time and money that would otherwise be lost due to unsuccessful Notified Body reviews. Contact us for more information about our review service.