The impacts of the EU Regulation on Medical Devices (MDR) and the EU Regulation on In-vitro Diagnostic Medical Devices on manufacturers will be focal topics at TÜV SÜD's stand at Medica, to be held in Duesseldorf from 12 to 15 November 2018. In addition, TÜV SÜD’s experts will advise manufacturers of the conditions they need to fulfil to access global markets for their products. (Hall 10, Booth C12)
MDR – stricter requirements for manufacturers and notified bodies
The new Medical Device Regulation (MDR) of the European Union replaces Directives 93/42/EEC on medical devices (MDD) and 90/385/EEC on active implantable medical devices (AIMD). It introduces stricter requirements for medical-device manufacturers and extends the responsibilities of notified bodies. This includes but is not limited to unannounced audits, product sampling and product testing. “Under the new MDR, for example, manufacturers must update the clinical evaluation and their pertinent technical documentation throughout the entire life cycle of a medical device, using systematically and actively collected data”, explains Dr Bassil Akra, Head of the Clinical Centre of Excellence at TÜV SÜD Product Service.
In addition, the manufacturers of Class IIa, IIb and III devices must draw up periodic safety update reports for each certified product and, where applicable, each product category or product group, and update these reports at regular intervals – biennially for Class IIa or annually for Class IIb and III products. Reports of implantable medical devices (Classes IIa and IIb) and Class III devices must be uploaded to EUDAMED and assessed regularly by the responsible notified body. Manufacturers of Class III medical devices and implantable devices, except custom-made devices, must draw up and annually update summaries of safety and clinical performance which are publicly available.
No grandfathering under the IVDR
The new Regulation on in-vitro diagnostic devices (IVDR) also differs in several aspects from the previous IVD Directive. The most important changes concern the clear expansion of the scope, the new classification system for product classes A to D, significantly stricter requirements regarding the responsibilities of the authorised representative for manufacturers outside the European Union, technical documentation and the evaluation of clinical performance. In addition, the regulation strengthens the role of the notified bodies in the registration of IVDs in classes B to D, which cover roughly 70% of devices. “When drawing up the IVDR, the European Union did not include a grandfathering clause”, emphasises Dr Thomas Theisen, Department Manager IVD at TÜV SÜD Product Service. “Given this, all in-vitro diagnostic medical devices that are already sold in the EU also need to be evaluated and, if necessary, certified in line with the new requirements.” By May 2022, IVD manufacturers must furnish evidence that their devices are in compliance with the requirements of the IVDR.
TÜV SÜD's 600-plus medical device experts can be found at more than 30 locations throughout the world, offering up-to-date detailed knowledge of requirements in the various target markets. Manufacturers benefit not only from TÜV SÜD's technical expertise, but also from its many international accreditations, such as NRTL, INMETRO and the Medical Device Single Audit Program (MDSAP). This considerably reduces their efforts involved in accessing international markets as well as their 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, through a single quality-management audit. TÜV SÜD was among the first organisations authorised within the scope of the programme and has carried out MDSAP audits since 2014. Manufacturers of medical devices can benefit from the service provider’s experience.
Further information on TÜV SÜD's services in the field of medical devices can be found on the Internet at http://www.tuv-sud.com/mhs.
Press-contact: Dr Thomas Oberst