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The Importance of the Medical Device Single Audit Program (MDSAP) and EU MDR Lead Auditor Certifications

Feb 1, 2024


By Kevin Walls, MBA, EAS Independent Consultant

The Medical Device Single Audit Program (MDSAP) is a certification program many medical device manufacturers are incorporating into their quality system. The US Food and Drug Administration (FDA), Health Canada, Brazil Agência Nacional de Vigilância Sanitária (ANVISA), Australia Therapeutic Good Administration (TGA), and Japan Ministry of Health, Labour and Welfare are the five regulatory agencies that have adopted MDSAP. Once a manufacturer obtains MDSAP Certification, the five participating regulatory agencies accept that the manufacturer’s quality systems have been determined to be in substantial compliance and will not inspect or audit the manufacturer unless they have a reason to believe that the company may be out of compliance because of something that particular regulatory agency discovered.

In order for a manufacturer to obtain MDSAP Certification, they must hire an auditing organization that has been qualified to conduct MDSAP audits and certify the manufacturers to MDSAP to perform the MDSAP audit. The audit entails determining whether the manufacturer’s quality system complies with the ISO 13485 Quality Management Systems Standard, as well as the medical device regulations in any of the five participating countries that the manufacturer distributes its medical devices.

Several auditing agencies only accept manufacturers’ internal audits that are performed by a certified MDSAP auditor. Once an auditor has obtained MDSAP Lead Auditor Certification, they are recognized as being qualified to perform internal audits for manufacturers who have MDSAP Certification or are working towards obtaining MDSAP Certification. Certified auditors can also assist manufacturers in setting up their quality systems to comply with MDSAP and pass an MDSAP audit by an auditing organization. Lastly, certified auditors can participate in MDSAP audits being performed by certifying auditing organizations to assist clients and help facilitate the MDSAP audits.

The EU Medical Device Regulation (MDR) or Regulation (EU) 2017/745 is a regulation that was adopted by the European Union in 2017 and became effective on May 26, 2021. It replaces the previous Medical Devices Directive (MDD) or Directive 93/42/EEC. The EU MDR has added or enhanced many parts of the Regulation, particularly regarding the areas of post market surveillance and clinical evidence. Many manufacturers have struggled with interpreting the new EU MDR and updating their MDD-compliant quality systems to meet the new EU MDR Regulation.

Like the MDSAP above, many notified bodies that audit and certify manufacturers to the new EU MDR require that those who perform internal audits to the EU MDR are certified to do so. Once receiving EU MDR Lead Auditor Certification, auditors can perform internal audits to the EU MDR. Certified auditors can also help clients develop or upgrade their quality system to be in compliance with the EU MDR and participate in notified body EU MDR audits to help facilitate the audits.

EAS Senior Independent Consultant, Kevin Walls, MBA has completed both the Medical Device Single Audit Program (MDSAP) and EU MDR certification programs. Kevin is an expert medical device regulatory consultant with nearly 36 years working in the medical device quality assurance and regulatory affairs field. For the last 24 plus years, Kevin has been a well-respected independent medical device regulatory and quality systems consultant. Kevin has serviced over 700 clients as a consultant and is available to assist EAS Consulting Group clients with their MDSAP and EU MDR compliance and certification needs.

Posted in Issue of the Month, Medical Devices and tagged .