Harmonisation for medical devices: TÜV NORD offers Medical Device Single Audit Program

The International Medical Device Regulators Forum (IMDRF) was established in February 2011 in order to discuss the future direction of regulatory harmonisation in the area of medical technology. One of its pilot projects is the Medical Device Single Audit Program, which is intended to create a common standard for quality management audits in the medical device sector. So far, the USA, Brazil, Canada and Australia have joined the initiative. TÜV NORD will offer MDSAP audits as from next year.

Up to now, medical device manufacturers have had to fulfil different specific requirements for the different countries where they want to sell their products. However, it will be possible to save time and money in future, as independent third parties – such as TÜV NORD – will be able to undertake activities normally performed by authorities abroad.

It usually takes years for a medical device to qualify for entry into a foreign market. If a company wishes to develop a global presence, the processes involved can be complex and time-consuming. Manufacturers have to communicate with the different official bodies, understand the relevant standards and complete the necessary paperwork. They also have to work with several different auditor teams if they want to register their products in different countries. However, within the framework of the MDSAP pilot project, authorised certification bodies can perform single audits which cover four of the most important export markets. At the end of the audit, a harmonised audit report is created, which is recognised in the USA, Brazil, Canada and Australia. This is an important step along the road to global harmonisation.

Japan has also joined the project. “At the moment, Japan is participating in the project as an observer. We very much hope that the Japanese authorities will recognise the benefits of the program”, says Manuela Ahlers, Business Development Manager at TÜV NORD. She is very pleased indeed that TÜV NORD is already taking part in the first phase of the pilot project and has passed the registration audit as a third party inspection organisation. “We carry out work on behalf of the official authorities, which saves a great deal of time when staff resources are limited. This means that the authorities can focus on critical products or incidents”, continues Ahlers.

MDSAP is based on the requirements of ISO 13485. Regulatory requirements of the participating countries which extend beyond the ISO requirements are also included in the program. Nothing will change as regards the country-specific requirements. The MDSAP pilot project began in January 2014 and will run until the end of 2016.

MDSAP will also be an important theme for TÜV NORD at the Medica 2014 World Forum for Medicine at the Messe Düsseldorf exhibition centre from 12 to 15 November. Visitors who want to learn more are warmly invited to our Stand 10H68 in Hall 10.