Posted 18 May 2017
By RAPS Staff
RAPS is bringing together a panel of Europe’s top industry experts to deliver a dedicated workshop on the new EU regulations for medical devices and in vitro diagnostic devices. ‘EU Regulatory Essentials, Medical Device and In Vitro Diagnostics: Transitioning from Current Directives to New Regulations’ will take place on 4 and 5 July in Brussels and will introduce and explain the new EU regulations.
Offered for the first time in Europe, the workshop will also feature the European Commission’s policy and legal officer in the field of medical devices, Salvatore Scalzo, who will provide insight and an introduction to the new legislation and its implications.
Scalzo is extremely well placed to offer advice and guidance on the new regulations with his role at the EC involving: negotiation of the proposed new EU regulations on medical devices; contribution to the International Medical Devices Regulators Forum, as well as being an EU member of the Global Medical Device Nomenclature Policy Advisory Group.
RAPS Executive Director Paul Brooks said: “RAPS is committed to understanding the specific needs of European regulatory professionals and supporting our European members as they prepare for, and implement, the new regulations and we are delighted to announce Salvatore Scalzo’s attendance.
“This workshop is a ‘can’t miss’ opportunity to learn from a select group of experts, including the European Commission’s MDR point person, and regulatory professionals who are closely engaged with the new emerging EU regulatory requirements. They will share important insights, unique perspectives and address the challenges of the new regulations.”
The program of speakers is now confirmed and joining Salvatore Scalzo of the EU Commission will be industry experts and key opinion leaders, including:
- Rainer Voelksen, FRAPS, vice president, regulatory and quality affairs, Occlutech
- Anja Wiersma, PhD, CEO and senior consultant, mi-CE consultancy
- Gert Bos, PhD, FRAPS, executive director and partner, Qserve Group
- Yvonne Middlefell, BA (Hons), RAC, FRAPS, senior director, Stellar Regulatory Consulting Ltd.
- Sabina Hoekstra-van den Bosch, MSc, PharmD, FRAPS, lead for European regulation global regulations and standards, Philips
- Bassil Akra, PhD, director, Clinical Centre of Excellence, TÜV SÜD, Product Service GmbH
- Rima Padovani, PhD, project associate, Medidee Services
- Michael Maier, senior partner, Medidee Services
The one-and-a-half-day workshop will include two general sessions relevant to all device/IVD manufacturers supplemented with two comprehensive tracks that delve deeper into the specifics of the new MDR and IVDR. The tracks will dig into new classification, conformity assessment, safety and performance, clinical/performance evaluation, technical documentation and postmarket requirements.
Brooks continued: “Highly regulated environments such as the medical device sector will always be subject to development and change. The new medical device regulations in Europe present a huge challenge to manufacturers but could also deliver improved confidence in the consistency and effectiveness of the EU regulatory process.
“By the end of our workshop members will be aware of the key changes introduced by the new regulations. They will also have received expert interpretation of new expectations and be prepared to develop transition plans to navigate market access (CE marking) expectations for both new and legacy devices being placed in Europe.
“If you are working in medical device/IVD regulatory affairs and quality assurance, this workshop will be invaluable as you prepare for the 2020 deadline.”
In addition to the Brussels workshop, RAPS has also produced a helpful ‘interactive guide ’ to the new EU Medical Device and IVD Regulations.
The Brussels event follows RAPS’ recent announcement to invest more than 2 million euro over three years implementing a strategic growth plan in Europe that includes launching new events and resources to serve the needs of regulatory professionals in the region.