LISAvienna: Business Meeting Regulatory Update, Medical Products 2016

In March 2016, the revision of ISO 13485 was published, the planned EU Medical Product Ordinance draws closer, and Austria receives a new, notified body for this product range. LISAvienna took these changes as an occasion to provide an overview of these new challenges and points out possible approaches in cooperation with the Ludwig Boltzmann Institute for Experimental and Clinical Traumatology. The crowds at the event were accordingly large. With more than 120 participants, the auditorium at the Lorenz Böhler Emergency Hospital was filled up to the last seat.

On 7 June, 2016, LISAvienna, together with the Ludwig Boltzmann Institute for Experimental and Clinical Traumatology, organized a business meeting regarding current changes in the regulatory sector.

In his welcoming address, Martin Meyer, Technology Expert for Medical Technology at LISAvienna, particularly pointed out the invitation to tender by the Vienna Business Agency that began on May 31 and is titled “Start Tech Vienna 2016”. Companies may each apply for up to 500,000 Euros for research projects that lead to product, service or process innovations in leading-edge technology fields.

During the first presentation of the afternoon, Heinz Redl, head of the Ludwig Boltzmann Institute for Experimental and Clinical Traumatology, presented the research projects and collaboration opportunities at the institute. He showed the diversity in medical products, which are already needed in research alone, but also how some high-tech products could be the result of years of intensive cooperative research. For example, he presented, among other things, the famous fibrin glue and the artificial, silk cruciate ligaments that were developed at the institute. Medical products associated with these products were also developed with the collaboration of the Ludwig Boltzmann Institute. Strong and long-standing cooperation with companies is a key to success – just like it is the case with >35 years of collaboration with Immuno/Baxter/Baxalta/Shire. All in all, the Ludwig Boltzmann Institute has a wide palette of expertise for developing new products in the field of intensive-care medicine and tissue regeneration – including its own competence centres for cross-thematic technologies and issues. Being embedded into the AUVA Research Center and the Austrian Cluster for Tissue Regeneration also played a key role for success.

Michael Pölzleitner, Branch Manager for medical device certification GmbH (mdc), addressed the new EU Medical Product Ordinance during the second presentation. In addition, before going to the main part of the presentation, Mr. Pölzleitner explained the current situation of the notified bodies in Europe and, particularly, in Austria. Due to the Europe-wide changeover and new requirements for notified bodies, the usual partner will no longer be available as the notified body in Austria in the future, but rather the Austrian branch office of mdc. The new Medical Product Ordinance will take effect in all member states 20 days after publication without a national implementation phase for the individual countries. The reforms to be expected range from the appointment of in-house staff responsible for legal regulations, to clarifying conditions for companies that have specialised in re-labelling or repacking medical products. All in all, the path to approving high-risk products will become more complex. In the future, the Austrian Medical Devices Act will only contain national regulations and will need to be thoroughly re-worked and slimmed down within 2 years.

During the third presentation, Martin Schmid, General Manager of Schmid KG , presented the development history and the central content of ISO 13485:2016 including the new requirements for quality management of medical products. ISO 13485:2016 was not published in English until March 1, 2016. There is no German language version yet. This norm does not overlap with ISO 9001:2015. It was important for many companies to find out that, for ISO 13485:2012, there is a transitional period of 3 years that is valid until February 28, 2019. In addition, re-certification for ISO 13485:2012 is no longer possible as of March 1, 2018. To ensure the smoothest-possible transition to the new ISO norm, a recommendation was made to carry out a gap analysis between current quality management and the new requirements and to specify a conversion timetable with the notified body in a timely manner. A project plan for adapting the processes and documentation was also recommended.

Heinrich Schima from the Centre for Medical Physics and Biomedical Technology of the Medical University of Vienna mainly illustrated, in his concluding presentation, the expected, practical effects of increased regulatory requirements in medical product development. He emphasised that the current version of the new EU guidelines, which the EU agreed upon on 25 May, is not yet publicly accessible. It will probably come into force at the end of 2016 or the beginning of 2017 and replace Directive 90/385/EWG regarding active implantable medical devices (AIMDD), 93/42/EWG regarding medical products (MDD) and 98/79/EG regarding in-vitro diagnostics (IVDD). The general transitional period is planned for 3 years, and 5 years for in-vitro diagnostics. Schima urgently pointed out the dangers of excessive regulation. Impressive examples were used to demonstrate the importance that biomedical technology has for modern medicine. As a member of the European Alliance of Medical and Biological Engineering and Science (EAMBES), Heinrich Schima discussed multiple meetings in Brussels and endeavours to heavily involve biomedicine engineers in the modification of regulatory processes.

Following the event, there was a chance to have a discussion over drinks and snacks at the buffet and to speak directly with the presenters - an opportunity of which people took extensive advantage.

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