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

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.  

Non-exhaustive list of examples (in alphabetical order): 

  • Clinical evaluation/performance evaluation process (including post-market clinical/performance follow-up), 
  • EU authorized representative contractual provisions, 
  • EU UDI assignment with the quality management system, 
  • Manufacturer financial coverage in respect of potential liability, 
  • Person responsible for regulatory compliance qualification and role,  
  • Records control, 
  • System for risk management, 
  • Vigilance and post market surveillance activities, including the associated corrective actions and preventative actions. 

The focused surveillance may allow NBs to specify MDR/IVDR requirements either not covered or only partially covered by the MDSAP audit report. Comparablyany non-conformities identified in a recent MDSAP audit report will likely trigger NB attention to those aspects in the MDR/IVDR surveillance audits. 

The MDCG 20-14 guidance clearly states that the NBs are fully responsible for their decisions as to the use and to what extent they use the MDSAP audit reports. Note that MDSAP audit reports can only be presented to the NB for consideration during a regular surveillance audit. Manufacturers cannot use MDSAP for the MDR/IVDR initial quality management audits or unannounced audits.   

The MDCG 20-14 also includes 2 Annexes.  

Part I – Explanation of relevant information in MDSAP audit reports 

Part II – Examples on how to correlations between MDR requirements to sections of MDSAP audit reports may be established.  

The MDSAP was developed by the International Medical Device Regulators Forum (IMDRF) to provide improved medical device safety and oversight using a global approach to auditing and monitoring, and now the MDCG 20-14 guidance document provides NBs and medical device manufacturers with guidelines as to how MDSAP fits into the medical device regulations MDR and IVDR that will be in full application in the near future.  


If your organization needs guidance, or just some extra support, on preparing technical documents for MDR, IVDR or, an MDSAP audit, Criterion Edge has experienced medical writers in a wide variety of documents including medical affairs, clinical sciences, technical, safety, and regulatory.  

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September 7, 2020

The Medical Device Regulation (MDR) and In Vitro Device Regulation (IVDR) Mandate that Device Manufacturers Have a Person Responsible for Regulatory Compliance (PRRC): Guidelines and Support

Author: Suzanne Broussard

The newly created Person Responsible for Regulatory Compliance (PRRC) position is a unique regulatory requirement that applies only to the European Union, and is a key area of responsibility for a person or persons under the Medical Device Regulation (MDR) and In Vitro Device Regulation (IVDR).  

The motivation for creating the PRRC positions is so that there is a qualified regulatory expert directly responsible for the manufacturing and the market surveillance and reporting systems to ensure the company is meeting the European Union requirements.  

The Regulations have a clear desire to add an additional level of scrutiny to the supervision and control of the manufacturing of medical devices, as well as relevant post-market surveillance and vigilance activities. Thus, the PRRC role is purposefully a unique position from the European Union Authorized Representative.  

The requirements, qualifications, and responsibilities of the PRRC is outline in Article 15 of both Regulation (EU) 2017/745 MDR and Regulation (EU) 2017/746 (IVDR). 

Article 15 of both MDR and IVDR state: 

“Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of in vitro diagnostic medical devices.” 

Manufacturers will be looking closely at how to fill these positions. Parent companies with more than one legal manufacturer under the organization needs to ensure that each legal manufacturer has its own PRRC. Micro or small business enterprises have the option to contract a PRRC (EU definition of micro and small businesses can be found in Regulation 2003/361/1C). 

Responsibilities 

The PRRC has at least 5 responsibilities clearly outline in Article 15. 

  1. Checking the conformity of medical devices in accordance with the quality management system (QMS) before the medical device is released; 
  1. Drawing up the technical documentation and keeping it up to date;  
  1. Making sure the post-market surveillance obligations are in compliance with EU regulations Article 10(9);  
  1. Fulfilling the reporting obligations referred to in reporting of serious incidents and field safety corrective actions (Article 82) and implementing acts (Article 86) 
  1. Ensuring the statement that investigational devices (Section 4.1 of Annex XIV) meet the GSPRs is signed. 

Guidance Document 

The Medical Device Coordination Group (MDCG) released a guidance document on 20 June 2020 addressing some of the questions about the person responsible.  

Medical Devices: Guidance document  

MDCG 2019-7 Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a “person responsible for regulatory compliance” (PRRC) 

The guidance clarifies the training and/or professional experience necessary to hold the position of PRRC. The qualifications for this role can be met with either education (certification/diploma) or experience. The PRRC does not have to perform all these duties themselves but is responsible for their completion.  

TEAM-PRRC 

To support those with the role of PRRC, a new not-for-profit European associating has been launched – TEAM-PRRC. The association represents it members at the highest level – the European Commission and Medical Device Coordination group (MDCG). TEAM-PRRC plans to provide the framework and rigorous analysis required to gain insight and influence the guidance that is being developed for the PRRC role. TEAM-PRRC aims to: 

  • Bring together all people with PRRC functions; 
  • Exchange experience on issues faced by PRRC in their daily activities; propose and exchange solutions. 
  • Establish, maintain, and develop a high level of professionalism of PRRC. 
  • Exchange information with health authorities in charge of national, European, and international regulation; promote understanding of PRRCs’ responsibilities to other stakeholders. 
  • Act as a moderator and support PRRCs in conflicts or disputes encountered during their day-to-day activities. 
  • Aim for enhancement of Public Health. 
  • Pursue for mutual assistance between TEAM-PRRC members. 

The newly created role of PRRC will bring many challenges for manufacturers and regulatory specialist, and there is a lot at stake for those considering taking this role. The regulations mandate penalties that are decided on the level of the member states for noncompliance and individuals taking this role need to be aware of the potential consequences.  

Criterion Edge is dedicated to providing support for medical device and pharmaceutical manufacturers, and we do this in part by keeping device manufacturers up to date on current events. For more information on the new MDR guidance documentsextension, and grace period, see our previous posts. 


Either way, Criterion Edge is prepared to provide expert medical writers to facilitate a timely submission.  

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