One of the more intimidating aspects of the EU Medical Device Regulation is the fact that it includes unannounced audits. They can take place at any time with no notice, and they’re meant to show a manufacturer’s quality management system in action day-to-day, not in theory at a scheduled review. Notified bodies are required to conduct at least 1 unannounced audit every 5 years (MDR, Annex IX), and it may be more frequent if the device poses a higher risk level, has a history of non-compliance, or if there are indications of a critical problem. Manufacturers should understand that audit readiness is not something that should be done in the fall. It is necessary to be continuous.
It is here that a structured EU MDR gap analysis tool comes in very handy.
Why is “Always Ready” a difficult task to pull off?
Manufacturers should be ‘compliance ready’, having audit-ready files and documentation for technical files, quality records, and post-market surveillance data, not just when an audit is scheduled. That translates to technical documentation, design history files, risk management records, PMS reports, and supplier controls, all of which must be up-to-date and consistent at all times, on all products. As the number of projects increases, most organizations begin to lose the thread: a CAPA becomes out-of-date, a supplier agreement expires, a technical file is a revision behind, no one knows until an auditor does.
What is the Gap Analysis Tool?
An effective gap analysis tool will directly compare your existing documentation and processes with MDR requirements, Annex by annex, and highlight where reality meets the gap. This tool is programmed to continually surface issues instead of waiting for a scheduled internal audit to detect a problem:
The latter is more significant than it appears. When notified bodies conduct an audit, they will specifically confirm that the processes actually occur as described in the QMS – for example, by auditing at least two key processes like design control, incoming component checks, or batch release. Gap analysis tools, which only look at documentation, tell only half a story – the best tools look at both.
Making use of findings to get ready
The actual value lies in the list of gaps, not in the list itself. A good tool should be focused on findings by risk and audit-relevancy, should have ownership, and should have tracking of remediation to closure – “audit-ready” should no longer be a hope; it should be evidence and a documented state. It also creates institutional memory: if key people are not around to help when the deputy needs to step in in the event of an unannounced visit, having a live, centralized record of where things are is really valuable.
The MDR Consultants Inc. Approach
Our team is comprised of former FDA reviewers and Notified Body auditors and understands what an auditor looks for on the other side of the table. We’ve been supporting medical device manufacturers to go beyond the interpretation of the regulation to the effective implementation of the regulation since 2019, and that begins with a gap analysis. We don’t just give you a list of deficiencies; we make sure to help you close them in a way that works, whether the audit is scheduled or not. That’s the foundation of our approach to Unannounced Audit Preparation MDR: a gap analysis is typically the quickest method to turn an audit into a non-event, if one is an event at the moment.
Looking to beef up your regulatory approach? Find consultants who can communicate in both the regulator’s and manufacturer’s vernacular; contact MDR Consultants Inc. today.
About The Author:
Isabel Osorio is the president and founder of MDR Consultants Inc. , a medical device consulting firm specializing in regulatory and quality consulting services for the medical device industry. She is a former member of industry following a 16-year career in the medical device field, where she gained extensive experience as an Engineer, a Lead Auditor and a Certified Trainer for Notified Bodies, and as a medical device consultant. While working on the front lines as a Clinical Specialist years ago, a chance encounter opened her eyes to the detrimental effects of companies skipping past proper quality controls and procedures.
This experience changed her perspective on the importance of Medical Device Standards and Regulations forever and inspired her to focus her career on helping medical device companies and professionals better understand the requirements to ensure confidence and competence in their implementation of relevant requirements. Product malfunctions can have harmful effects on someone’s life, including death, and that patient could be you or a loved one. That is why patient safety is at the heart of her MDR Consultant’s mission to provide best-in-class training and consulting services. You can reach her at info@mdrconsultants.com