Preparing for Notified Body Audits under EU MDR – Ensuring Compliance & Continual Improvement

Manufacturers in the dynamic global medical device sector today are subject to a wide range of compliance assessments from different regulatory agencies wherever they operate whether its hometown and export zones. The hurdles are many, ranging from CE mark certification through surveillance and recertification audits by notified organizations and regulatory evaluations by organizations including the U.S. FDA, EU regulatory bodies, Brazil’s ANVISA, Australia’s TGA, and Japan’s MHLW. Consider putting some useful suggestions into practice to succeed in these audits and guarantee compliance. They can cause more productive and less stressful experiences.

Are you ready for an audit by a notified authority under the European Medical Device Regulation (EU MDR) at your medical device company? It is essential for medical device makers who want to sell their products in Europe to go through a rigorous certification procedure through a notified authority. These organizations, authorized to act on behalf of the European Union, guarantee that goods comply with the key requirements of the EU MDR and any other relevant laws or recognized norms.

Process of Certification

A thorough examination of the business’s technical paperwork is required for the initial device approval certifications. This could be a design dossier for Class III devices or a technical file for Class IIa and IIb devices. Most firms also get their Quality Management System (QMS) certified in line with EN ISO 13485 in the Europe. The audit conducted by the notified body may include a careful examination of both the QMS specifications and the technical files required for device approval or product families. One or more auditors may need several days to conduct such an evaluation in order to completely determine compliance with the QMS and EU MDR requirements.

Monitoring audits

Once the QMS has been certified, the notified authority may carry out yearly surveillance audits to check on ongoing compliance and QMS improvement. This guarantees that the business constantly complies with legal obligations and upholds the highest standards of operation excellence.

Unannounced Audits

Notified entities may also conduct unannounced audits of medical device makers, particularly in places where manufacturing is carried out, under the demands of the EU Parliament. Unannounced audits strive to assess conformity at any moment, which can be upsetting for organizations trying to maintain their usual business activities. This practice is like that of the FDA.

Critical to Compliance

Medical device companies must build a strong QMS that supports all required documentation and adherence to relevant regulatory requirements and standards in order to be well-prepared for notified body audits. Continuous improvement, which entails examining post-market data to find possibilities for improvement and satisfy consumer wants and expectations, is a critical component.

How to Get Ready for Regulatory Audits

Always Be Prepared: Regardless of whether an audit is planned or unexpected, always be ready. Unannounced inspections, which are increasingly carried out by the FDA and EU notified organizations, highlight how crucial it is to always be prepared. Keeping up with standards and laws is essential for both scheduled and unforeseen audits.

Create a framework for audit management

Make a thorough audit checklist using ISO 13485 or the EU MDR regulations. Create a flowchart that outlines expected auditor inquiries and the pertinent objective evidence needed to show compliance. Determine the precise regulatory variations for each nation where your items are marketed.

Choose teams for the front and back rooms:

Establish a “back room” with support staff and subject matter specialists, and a “front room” where your quality or regulatory affairs staff can speak with auditors directly. The necessary material, such as organizational charts, facility layouts, quality manuals, policies, and top-level processes, should be accessible to the back-room crew.

Subject-Matter Experts in Coaching:

Prepare subject-matter specialists in design, production, and other divisions to communicate with auditors in an efficient manner. Encourage them to ask questions for clarification if necessary, steer clear of giving incomplete responses, and hold off on talking about extraneous subjects in order to stay on topic and be understood.

Conduct Mock Audits

Staff employees who might be involved in an audit can become familiar with anticipated inquiries and practice appropriate responses by participating in mock audits. To increase their comprehension of the topic and confidence in it, encourage team members to independently evaluate pertinent information.

Think about cultural variations

Adapt the audit to the interests and protocols of the foreign auditors that visit your facility. If interpreters are present, be understanding of any language problems and treat them with respect and kindness. Cultural customs can affect what the auditor expects.

Obtain information on the auditor

Learn in advance about the particular cultural expectations and needs of auditors. Ask employees who have dealt with auditors from a specific nation for help, or ask the auditors up front if you have any questions. It never hurts to inquire, even though some auditors might be eager to share information while others would not.

Medical device manufacturers can improve their readiness, retain compliance, and achieve positive results in audits conducted by notified authorities and other regulatory bodies by implementing these useful recommendations into their audit management approach.


Compliance with EU MDR and passing notified body audits are requirements that cannot be waived for medical device companies looking to commercialize their goods in Europe. Organizations may confidently confront both scheduled and unscheduled audits and guarantee the safety and efficacy of their medical devices in the European market by giving priority to a strong QMS, adherence to regulatory requirements, and a culture of continuous improvement.

About the Author

Waqas Imam

S. M. Waqas Imam is associated with TS Quality as a Regional Partner. He is also an ambassador of Medical Device Community. He is an Industrial Engineer by qualification and served the manufacturing industry since 2011. He is also IRCA CQI Lead Auditor of ISO 9001 and other management system standards. He had served as Quality Assurance and Regulatory Affairs Manager in QSA Surgical Pvt. Ltd. and Ultimate Medical Products. He managed requirements of ISO 13485:2003, EU directives, CE marking and FDA. He also served as Expert Blog Writer for 13485Academy and wrote expert articles on various topics of ISO 13485:2016.