Aligning Clinical Strategies with MDR & MEDDEV Regulatory Requirements, Obtaining a Greater Volume of Clinical Data to Support Regulatory & Access Goals, Integration of Unique Initiatives such as IIS to Broaden Indications & Maintain Budgets
With the publication of the Medical Device Regulation in May of 2017, the medical device industry has engaged in a multiplicity of regulatory revision operations spanning all levels of manufacturing corporations, in order to meet compliance within the three-year transition time. Clinical affairs teams are highly impacted by the new rules, as more trials are now required by health authorities across the Union due to the mandatory re-registration of CE marked devices, as well as the overall demand for increased clinical data. Concerns arise among clinical professionals surrounding lack of clarity in the MDR and MEDDEV 2.7.1 rev. 4 mandates for additional data, creating confusion within the industry as to notified body and competent authority expectations. Similarly, with a more stringent framework than under the MDD for claiming clinical equivalence, many manufacturers are considering alternatives to meet new and updated requirements.
The 10th edition of Q1’s European Medical Device Clinical Research conference will continue to provide executives with an unparalleled educational opportunity, through practical workshops, lively discussions as well as traditional presentations delivered by competent authorities, notified bodies and thought industry leaders, ensuring a distinct mix of session formats. Further topics of the utmost importance will also be addressed and debated, focusing on critical steps of clinical study design, initiation, on-site management and post-market follow-up, in addition to opportunities in supporting investigator-initiated trials in full legal compliance. With such a variety in formats, speakers and topics, the Anniversary edition of the Q1 European Medical Device Clinical Research conference is a must-attend for forward-thinking clinical affairs professionals looking to gain knowledge from expert speakers as well as engage in peer to peer learning, all while benefiting from a dynamic networking platform.
Eric Jahnke | Sr. Marketing Manager | Q1 Productions
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