The impact of the new Medical Device Regulation (MDR) on manufacturers of medical devices will be a focus for TÜV SÜD’s presence at Medica in Düsseldorf from 13–16 November 2017. The TÜV SÜD stand will also supply information on the new In-vitro Diagnostic Regulation (IVDR) and the Medical Device Single Audit Program (MDSAP). In addition, TÜV SÜD’s international experts will advise medical device manufacturers of the conditions they need to fulfil to access global markets for their products. (Hall 10, Stand C12).
Under the new Medical Device Regulation (MDR) of the European Union, the powers of Notified Bodies with respect to assessment of clinical evidence after products are placed on the market have now been expanded to include unannounced audits, sampling and product testing. “In addition, medical device manufacturers are required to collect a far greater range of clinical data than previously to conduct ongoing evaluation of potential safety risks and benefits”, notes Dr Bassil Akra, Director of the Clinical Centre of Excellence at TÜV SÜD Product Service. For example, manufacturers are obliged to conduct continuous updates of clinical evaluation and the associated documentation throughout the entire product life cycle, and must systematically and proactively collect clinical data for this purpose. In addition, manufacturers of Class IIa, IIb and III devices must produce a safety report for each device and, if applicable, for each device category or device group. These reports must be updated at regular intervals, with annual revision stipulated as mandatory for manufacturers of Class IIb and III devices. In the case of implants (Class IIa and IIb) and Class III devices, the report must be regularly assessed by a Notified Body. Manufacturers of implantable devices and Class III devices (except custom devices) must produce summarised reports on device safety and clinical performance and update the report annually at minimum.
IVDR does not include a “grandfather clause”
The new In-vitro Diagnostic Regulation (IVDR) likewise differs from previous regulations in numerous aspects. The most important changes concern major expansion of the scope of the Regulation, a new risk-based classification system of product classes A to D, significantly more rigorous regulations governing technical documentation and clinical performance evaluation, and greater involvement of Notified Bodies in the approval of Class B to D in-vitro diagnostic devices (IVDs) – which accounts for approximately 70 per cent of these products. “Manufacturers must also be aware that the European Union did not include grandfathering provisions when drawing up the new IVDR”, warns Dr Dieter Schönwald, Head of In-vitro Diagnostic Devices at TÜV SÜD Product Service. “This means that all In-vitro diagnostic devices on the EU market will need to be re-evaluated under the new requirements, and may require re-certification.” Manufacturers of IVDs have until May 2022 to submit evidence that their products comply with the new provisions of the IVDR.
TÜV SÜD’s medical device experts are represented at over 30 locations worldwide. They offer cutting-edge in-depth knowledge about the requirements of the target markets. Manufacturers benefit from TÜV SÜD’s specialist expertise and extensive international accreditations, which can considerably streamline the efforts they require to access many international target markets for their products.
TÜV SÜD also performs audits under the Medical Device Single Audit Program (MDSAP). Established by the International Medical Device Regulators Forum (IMDRF), the MDSAP project provides companies with a single quality management audit which can confirm their compliance with the regulatory requirements in an array of countries (Australia, Brazil, Canada, Japan and the USA). TÜV SÜD was among the first organisations to gain accreditation for this programme and has conducted MDSAP audits since 2014. Medical device manufacturers can benefit from TÜV SÜD’s experience in this field.
For more information on TÜV SÜD’s services in the field of medical devices, visit www.tuev-sued.de/mhs.
Press contact: Heidi Atzler