Key topics at TÜV SÜD's stand at MedtecLIVE, to be held in Nuremberg from 21 to 23 May 2019 will be the new EU Regulations on medical devices (MDR) and in-vitro diagnostic medical devices (IVDR) and how they affect medical-device manufacturers. In addition, TÜV SÜD's experts will be on hand with information about TÜV SÜD's testing and certification services for the global market access of medical devices and the requirements of Notified Bodies concerning artificial intelligence (AI) in medical devices. (Hall 10.0, Stand 228)
The new Medical Device Regulation (MDR, EU 2017/745) of the European Union repeals and replaces Directive 93/42/EEC concerning medical devices (MDD) and Directive 90/385/EEC relating to active implantable medical devices (AIMD). It applies to all medical device manufacturers seeking to place their products on the EU market, and imposes strict demands on both the manufacturers of medical devices and the Notified Bodies, which manufacturers must consult for conformity assessment of medical devices in higher risk classes.
Given this, all manufacturers of medical devices in classes I to III now need to address the new requirements in a timely manner. For the first time, the Medical Device Regulation (MDR) also includes requirements for products that are not medical devices per se. Changes concern the classification of products, the essential requirements applicable so far, technical documentation, clinical data, post-market surveillance and the quality management system. “Manufacturers need to prepare now and coordinate their approach with a Notified Body to manage the transition successfully and ensure compliance with the requirements of the new MDR”, warns Norbert Stuiber, Global Director Sales and Strategic Marketing at TÜV SÜD.
The medical-device market is characterised by two factors: high demand for innovative products, in conjunction with ever-shorter development cycles and strict regulatory requirements. Efficient product design and development and successful completion of individual design phases are critical for the efficient and effective introduction of new and compliant medical devices. “By supplying modular Medical Testing Services, we support manufacturers of medical devices right from the outset and throughout all phases of their products' life cycle”, says Rouven Rosenheimer, Senior Account Manager TÜV SÜD Product Service GmbH. “In our capacity as an accredited testing laboratory, we assess partial aspects of your devices for their conformity with the applicable standards even before the device is completed.”
Product design and development at the manufacturers include the phases of definition and planning, design and development, verification of design requirements and validation of customer requirements, global market launch and life-cycle management. By working closely with the TÜV SÜD experts right from the start, manufacturers can identify non-conformities with the standard at an early stage, thereby reducing the risks of major re-designs and time to market.
As digitisation advances, more and more medical devices also include interfaces (user interfaces or devices) that are subject to cybersecurity. Some or all of these interfaces might require protection of confidentiality, privacy, integrity and availability. The testing laboratories operated by TÜV SÜD and its partners offer a complete package of assessment and testing services for the cybersecurity of medical devices. Assessment ideally starts with the assessment of the manufacturer’s processes within its quality management system aimed at ensuring safety by design and with the assessment of the security concept for the concrete medical device. Once the design activities have been completed and a prototype is ready, our testing services (e.g. fuzz tests, penetration tests, tests of known vulnerabilities) start.
Its 750-plus medical device professionals can be found at more than 30 locations throughout the world. Manufacturers benefit from both TÜV SÜD's technical expertise and its extensive international accreditations, including NRTL, INMETRO and the Medical Device Single Audit Program (MDSAP). These benefits considerably reduce the efforts involved in accessing international markets and shorten time to market. The Medical Device Single Audit Program (MDSAP) is a project of the International Medical Device Regulators Forum (IMDRF). The programme enables manufacturers to ensure compliance with the regulatory requirements of several countries, i.e. Australia, Brazil, Japan, Canada and the USA, by means of a single quality-management audit.
In addition to TÜV SÜD's presence at the exhibition stand, Dr Andreas Purde, Global Director Functional Safety, Software and Digitisation at TÜV SÜD Product Service GmbH will speak on AI in medical devices and the requirements of Notified Bodies (“KI in Medizinprodukten – Anforderungen einer Benannten Stelle”) on Wednesday 22 May 2019, 2pm. The talk – given in German only – will be held as part of the MedTech Summit.
Further information about the EU Medical Device Regulation, the key changes it involves and TÜV SÜD's services in this context can be found at https://www.tuev-sued.de/produktpruefung/branchen/medizinprodukte/marktzulassung-und-zertifizierung/eu-marktzugang/mdr-eu-medizinprodukteverordnung
Further information about TÜV SÜD's Medical Testing Services and other services for medical devices can be found at: https://www.tuev-sued.de/produktpruefung/branchen/medizinprodukte
For further information about the cybersecurity of medical devices and the relevant services provided by TÜV SÜD, go to: https://www.tuev-sued.de/produktpruefung/branchen/medizinprodukte/pruefung-bewertung/pruefung-aktiver-medizinprodukte/cybersecurity-von-medizinprodukten
Press-contact: Dirk Moser-Delarami