September 28, 2020

Notified Bodies Received New Guidance from MDCG on the Use of MDSAP Audit Reports for MDR and IVDR

Author: Dr. Suzanne Broussard  | September 28, 2020

Medical device manufacturers received clarification on how the European Commission’s Medical Device Coordination Group (MDCG) will allow Notified Bodies (NBs) to use Medical Device Single Audit Program (MDSAP) audit reports. The punch line of the MDCG 20-14 guidance document published in August 2020 is that NBs can possibly “take into account the scope and outputs of manufacturers’ recent MDSAP audit reports as an input for developing surveillance audit programs.”    

MDCG stresses that the Medical Device Regulations (MDR) and In Vitro Device Regulations (IVDR) remain applicable in their entirety. Surveillance audits are mandated by law, as is their frequency, and the EU auditor’s competencies. Therefore, the “use of MDSAP audit reports is possible only where MDSAP audits covers similar of equivalent MDR/IVDR requirements.”  

Canada mandates the use of MDSAP audits, and 4 other countries allow their use.

MDSAP offers a harmonized auditing program to medical device manufacturers in Australia, Brazil, Canada, Japan, and US. See our previous posts for more information on MDSAP, what it is, what to expect, and tips to ace the MDSAP audit.

Are You a Global Medical Device Manufacturer That Is Tired Of Multiple Regulatory Audits? Consider Transitioning To The MDSAP Single Audit

What To Expect During An MDSAP Audit

9 Tips To Ace The MDSAP The First Time

The MDCG 20-14 guidance now allows NBs in the European Union to take into account the manufacturers’ recent MDSAP audit reports’ scope and outputs as input for developing the surveillance audit program that defines more precisely the manner of the surveillance audit. Several examples are provided in which conformity of a positive quality management system through MDSAP might lead to a reduction of aspects already covered by MDSAP audit reports.  

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August 12, 2019

9 Tips To Ace The MDSAP The First Time

Author: Suzanne Broussard

Take the advice of industry experts and AOs—the key to acing the MDSAP audit is to prepare, prepare, prepare.

The MDSAP audit process is intense in that it is designed to provide thorough coverage of QMS and multiple jurisdictions regulations. Remember, your organization already maintains a level of compliance in all countries they sell devices. MDSAP simply rolls all these regulatory requirements into an efficient process. Here are a few tips to keep in mind when preparing for the MDSAP audit.

1. Look closely at the MDSAP Audit Model to determine exactly what the Auditing Organization (AO) will need. The MDSAP Audit Model is the AOs guide. Everything needed for the audit is clearly laid out in this comprehensive guide. Each of the 90 questions the AO will ask is contained in this guide. And, each question is cross-referenced to relevant sections of ISO 13485:2016 and other specific requirements of medical device regulatory authorities participating in the MDSAP program.

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July 29, 2019

What To Expect During An MDSAP Audit

Author: Suzanne Broussard

Risk Assessment is the Cornerstone of the MDSAP Audit

When preparing for the MDSAP audit, it is important to understand that the audit focuses heavily on risk-based processes, outsourced processes, and validation activities. MDSAP is based on the international quality systems standard ISO 13485:2016, which requires organizations to consider risk from device conception through its lifetime of use. This Risk Management  includes the device manufacturer and the supply chain.

Check out our Resources page for our whitepaper on MedDev 2.7/1 Equivalence and Risk/Benefit Profile.

There are seven “Processes” in the MDSAP audit. FDA’s vision of how all these processes link together is depicted in Figure 2.

The first four “Primary” processes, depicted in the dark blue boxes, and the “Supporting” Purchasing process were all built on a foundation of Risk Management. The other two Supporting processes (note that Device Marketing Authorization and Facility Registration links to two processes), depicted in the light blue boxes, fulfill the requirements of the participating regulatory authorities. There are 90 total tasks.

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May 9, 2019

Are You a Global Medical Device Manufacturer That Is Tired Of Multiple Regulatory Audits? Consider Transitioning To The MDSAP Single Audit

Author: Dr. Suzanne Broussard

MDSAP as a Single Regulatory Audit 

The Medical Device Single Audit Program (MDSAP) is now in year three of voluntarily allowing medical device manufacturers to satisfy requirements of multiple regulatory jurisdictions with a single audit. Understanding the basics of MDSAP is the first step to determining if this is right for your organization.  

Device manufacturers are starting to accept this more harmonized auditing program, with over 2,700 manufacturers having undergone an MDSAP audit as of December 2018 (Figure 1). The significant increase in audits in 2018 reflects Health Canada’s hard deadline of January 1, 2019 for device manufacturers to comply with MDSAP in order to sell medical devices in Canada. While there were plenty of concerns about the transition, Health Canada received over 3,000 MDSAP certifications or transition submissions accounting for 90% of medical manufacturers operating in Canada. The remaining 10% are companies with very low or no sales, meaning they may likely pull out of the market.  

Number of manufacturers that have undergone MDSAP audit as of December 2018.

Several early adaptors are lauding the MDSAP program for saving time and limiting company resources needed for auditing agencies. These outcomes are in line with IMDRF’s primary goals for creating MDSAP, which are to “…jointly leverage regulatory resources to manage an efficient, effective, and sustainable single audit program focused on the oversight of medical device manufacturers.”  

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October 12, 2017

Medical Device Single Audit Program: The Basics

Holding Globe in One Hand

Recently, the Regulatory Authority Council issued a report that the Medical Device Single Audit Program (MDSAP) has been successful in its pilot, and will therefore continue. So what is the MDSAP and why is it important? (more…)

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