11th November 2019
As the market for medical devices is highly dynamic, new medical devices must have a short time to market and, at the same time, comply with a host of national regulations before their market launch. TÜV SÜD will showcase its services in this area at this year's MEDICA (Hall 10, Stand C12). In addition to product testing, TÜV SÜD's services include extensive medical testing services aimed at reducing design and development costs, mitigating project- and product-related risks and ensuring faster market access. The trade fair will take place from 18 - 21 November.
“For the success of medical devices, time is of the essence. Launching innovations quickly gives manufacturers critical competitive edge”, says Norbert Stuiber, Global Director Sales and Strategic Marketing at TÜV SÜD Medical & Health Services. Keeping this in mind, TÜV SÜD's Medical Testing Services span early assessment of the test strategy, support during design and development, ‘early-bird’ assessment and assistance with global market access (GMA). Within the scope of these testing services, medical technology and medical devices undergo extensive testing in areas such as electrical safety and electromagnetic and environmental compatibility (EMC), but also mechanical testing. The company also provides biological and chemical validations on biocompatibility, toxicology, microbiology and sterilisation performance. TÜV SÜD has thus further expanded its service portfolio compared to last year.
New regulation raises the bar
The Medical Device Regulation (MDR), which will become mandatory from May 2020 onwards, aims at further improving the quality and safety of medical devices on the EU market. Norbert Stuiber says, “To this end, the EU Regulation has refined the applicable requirements, making them even more precise and rigorous.” While manufacturers and Notified Bodies have been preparing for the Regulation for almost three years, many of them are still facing some challenges.” The clinical evaluation and the pertinent documents, for example, must be regularly updated with data from clinical practice throughout the life cycle of a device. TÜV SÜD is one of only six organisations that have been officially registered as Notified Bodies so far. Overall, 40 organisations in total have applied for recognition as Notified Body. Notified Bodies must be involved in the approval process of medical devices in higher risk classes.
Workout for in-vitro diagnostics
By May 2022, manufacturers will also need to demonstrate their products’ compliance with the requirements of the new regulation on in-vitro diagnostics (IVDR). The scope of this regulation has been significantly expanded in areas such as the classification system of medical devices and the requirements regarding the authorised representative for manufacturers located outside the European Union, but also for technical documentation and evaluation of clinical performance. In addition, the role of the Notified Bodies in the approval of the majority of products has been expanded. In-vitro diagnostics that have already been placed on the market must also be re-evaluated and, if necessary, re-certified with the involvement of a Notified Body.
IT security and new production methods
An increasing number of medical devices now also offer interfaces for Internet access. These devices must demonstrate that they protect the confidentiality, integrity and availability of the data and the respective system. TÜV SÜD offers comprehensive tests and evaluations, ensuring IT security of medical devices. Further services concern 3D-printed medical devices and their methods of additive manufacturing which offer completely new opportunities in design and geometries.
Technical talks by TÜV SÜD at MEDICA
Thomas Ring, Senior Account Manager Global Market Access at TÜV SÜD Product Service, will present a talk (in German) on wireless technology in medical devices, focusing in particular on the normative and/or legal requirements of global radio licences for medical devices (“Funk in der Medizintechnik” at COMPAMED Forum on Wednesday, 20 November, 12-12.30 pm).
MEDICA, the world's largest trade fair for medical devices, health, pharmaceutics and health care and their suppliers, is considered a must in this sector. The trade fair is held parallel to the COMPAMED trade fair, which targets the components, precursors and raw materials used in the medical industry.
TÜV SÜD, one of the world's leading Notified Body's for conformity assessment of medical devices, is represented at the trade fair by a team of 50 experts. With 800-plus employees in the field of medical devices across more than 30 locations TÜV SÜD has state-of-the-art detailed knowledge of the specific requirements in the individual target markets. 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). Under the MDSAP, one quality management audit is all it takes to furnish proof of compliance with the regulatory requirements in Australia, Brazil, Japan, Canada and the USA. Tests and audits not only enable stakeholders to prove that their devices are in compliance with the relevant regulatory requirements; they also ensure the safety and quality of devices, which are factors of fundamental importance for customer satisfaction.
Further information about TÜV SÜD's services on medical devices are available here.
Press-contact: Dirk Moser-Delarami
Chọn vị trí