The EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) have raised the bar for compliance. Preparing regulatory documentation is no longer a simple checklist - it is a resource-heavy process. If your regulatory team is struggling to get the job done, outsourcing might be the smartest move. Here are five signs that it’s time to seek external expertise.
1. Your Team is Overwhelmed by Regulatory Complexity
MDR and IVDR introduced stricter requirements for clinical evidence, risk management, and post-market surveillance. If you have extended your RA team already but they are still struggling with the interpretation of the of the requirements in the Annexes and MDCG guidance documents, external consultants can provide clarity and speed. They have the expertise and knowledge required for a submission and can tell you ‘what is good enough’.
2. Deadlines are Slipping
Missed deadlines can delay product launches and revenue streams. If your regulatory submissions are consistently late, outsourcing can help you meet critical milestones.
The compilation of submission documentation is often underestimated. In addition we have seen management tightening the timelines and pushing on deadlines to avoid delays in product launches. But many regulatory documents need updating to the latest requirements and new verification tests or validations need to be performed. A remediation plan, starting with a GAP assessment of your current technical documentation or design history file is key for your project plan and timelines. If offers clarity to management as it provides a clear picture of deliverables and timelines.
Often the gaps require input or support from R&D departments for the (re)writing of test protocols, execution of testing and report writing. If external test labs are involved, we often see delays in the planning, not mentioning failing test results messing up timelines.
External experts can help you identify the compliance gaps, help create a realistic planning and support your R&D and RA teams with expert advice and hands-on support.
3. Gaps in Clinical or Performance Evidence
Clinical evaluation reports (CERs) and Performance evaluation reports (PERs) are mandatory under MDR and IVDR. If your documentation lacks sufficient data or your team struggles during notified body review, external experts can rewrite your clinical strategy or strengthen your evidence base.
Note: a simple update of your (MDD or IVDD) CER or PER is not sufficient for a MDR are IVDR submission. To include all new requirements the clinical and PMCF/PMPF strategy needs to be reconsidered, and the clinical evaluation plan needs rewriting. In many cases existing clinical and performance data are not sufficient to meet MDR and IVDR requirements and new data are required to support the intended use and claims made for your device.
4. Limited Internal Resources
Small and mid-sized companies often have lean regulatory teams. Even if they have sufficient knowledge of the regulatory requirements, the submission process is a challenge for small teams. External support offers flexible scaling without permanent hires, they can provide hands-on support, review your documentation for compliance or write an overarching summary of your technical documentation to facilitate the review process.
5. Increased Scrutiny from Notified Bodies
Notified Bodies are applying MDR and IVDR requirements rigorously. If your submissions receive major non-conformities, an expert review can prevent costly delays.
Many submission files lack essential documentation or show inconsistencies between different documents. I.e. The description of the intended use or indications is not consistent throughout the submission file. Documents are not properly linked, or risk management is not aligned with the verification testing, clinical evaluation, post market surveillance plans or not properly addressed in labelling and IFU. All these inconsistencies slow down the conformity assessment.
Better safe than sorry. It pays off hiring expert to review if your submission documentation is complete and all requirements are met. It will reduce the number of questions and non-conformities during the review process and shortens time to market. The cost for an expert outweighs the extra costs during the submission review and safes you a lot of corrections!
Conclusion
Regulatory compliance under MDR and IVDR is non-negotiable and often underestimated. External support can provide expertise and hands-on support. It will improve your efficiency and peace of mind. If any of these signs sound familiar, partnering with experienced consultants could be the key to staying compliant and secure your future market access.