How to get the most out of the Medical Device Single Audit Program

Peter Rose, managing director, Europe at Maetrics offers advice on getting the best out of the MDSAP (Medical Device Single Audit Program).

The MDSAP (Medical Device Single Audit Program) program was initiated ten years ago by the IMDRF (International Medical Device Regulators Forum); it is a global approach which is devised to audit and monitor the manufacturing of medical devices, with the objective of improving their safety and effectiveness. The aim of MDSAP is to offer an “all-in-one” audit and to provide evidence of compliance with the ISO 13485 standard and the medical device regulations in Canada, Brazil, Japan, Australia and USA. Canada is the only country to enforce MDSAP as mandatory, starting from January 1, 2019.

MDSAP typically takes three years from start to completion and it includes three different audits, these are: the initial audit, the surveillance audit and the recertification audit. Occasionally, in some unique cases, special audits are conducted by the Regulatory Authorities and unannounced audits may be conducted.

As the regulatory landscape continues to evolve it couldn’t be more important for medical device manufacturers to be up to date with the changes and to keep completely informed particularly when it comes to making more cost-effective choices. In order to assist with this, we have listed the main benefits and opportunities for manufacturers which can be derived from MDSAP.

Keeping it simple

MDSAP covers the existing ISO 13485 standard and country specific requirements which means that it is not based on any additional ISO standards or regulatory requirements. This means the normative framework remains unchanged and medical device manufacturers can benefit from the process of standardisation and harmonisation within the QMS, and also in the regulatory submissions.

Co-ordinated audit requirements

MDSAP is built on multiple regulations from five different countries meaning that any manufacturer who complies with the audit requirements of just one of these countries will automatically comply with the requirements of the other four participating countries. Preparing for and responding to audits and inspections within various markets is a time consuming challenge which is significantly reduced by MDSAP. It might seem to some that the initial implementation phase is restrictive but ultimately the benefits that MDSAP will bring will far outweigh the initial constraints.

Available support

The FDA website provides guidance to stakeholders by making policies, procedures, templates and forms publicly available. On the websites of the FDA and other regulatory authorities it is also possible to find links to descriptions of procedures, templates and forms. It is advisable for manufacturers to follow this available guidance in order to ensure compliance with MDSAP is as seamless as possible.

Larger market access

MDSAP allows for the increased acceptance of audit reports through more sharing and extra involvement of various regulators. This means that certain manufacturers may choose to expand their participation to other markets included in the MDSAP program, and in fact, this could be seen as a manufacturer’s commitment to product quality and regulatory compliance. If done correctly, then it can be used as a promotional tool to create a marketing differentiation.

Saves time and money

As MDSAP stipulates that one audit can suffice in the place of five it means the overall number of audits or inspections is reduced for medical device manufacturers and they can optimise the number of resources as well as the amount of time which will ultimately be spent on audit activities.

The MDSAP should also have a positive impact on the number of Auditing Organisations (AOs); currently the number of AOs is not as large as expected , but it is possible that MDSAP will eventually provide a broader choice of third party AOs as other organisations (other than Notified Bodies) will be recognised. 

Engaging with experts

There are many MDSAP subject matter experts who can add timely and valuable support to manufacturers going through the MDSAP audit preparation. Many consultancy organisations will engage and collaborate with the best MDSAP experts who are appropriately trained to bring about the maximum amount of compliance and regulatory success to manufacturers.

There are a lot of stakeholders involved in the MDSAP process; however the MDSAP programs aims to consolidate the efforts of the stakeholders in a collaborative effort for the ultimate benefit of the medical device industry. Some stakeholders may be hesitant to embrace this new approach; however, it is quite clear that the benefits of compliance outweigh the initial constraints and risks and will benefit the medical device industry as a whole.