The Regulatory Affairs Professionals Society (RAPS) and The Organisation for Professionals in Regulatory Affairs (TOPRA) have joined forces to deliver a workshop to help regulatory professionals understand the impact of the EU’s new Medical Device Regulation (MDR) on combination products.
The workshop, entitled Addressing the Impact of the EU MDR on ‘Combination’ Products, will take place in Brussels, 20 November 2018, and bring together representatives of the European Commission, Member State medicinal and medical device authorities, notified bodies and industry experts to explore the complex issues of MDR specific to combination products.
The goal of the workshop is to generate white papers highlighting practical considerations to be shared with regulators and other stakeholders as they deliberate on implementation issues.
The workshop will include a brief review of the changes MDR will introduce, but more time will be devoted to discussing the anticipated practical implications of the changes and sharing the concerns and expectations of all stakeholders as the regulators establish future implementation expectations.
Paul Brooks, executive director of RAPS, commented: “MDR is the single biggest challenge currently faced by those involved in the regulation of healthcare products. Combination products are particularly challenging to manage, and collaboration across the sector is essential if we are to consistently understand the regulators’ interpretations and expectations in meeting the new requirements.”
