July 6, 2020

[FEATURED] Devices Containing Ancillary Medicines Likely To Need ‘Near Full Review’ Under MDR

Latest EU guidance highlights the challenges ahead for class III, high-risk, device/drug combinations when preparing for compliance under the tougher requirements of the MDR.

Do you like it?0
June 22, 2020

[FEATURED] New EU Association Supports EU Regulatory Compliance Role As Responsibilities Take Shape

Those appointed in the new role of Person Responsible For Regulatory Compliance (PRRC) under the EU MDR are likely to have a tough job ahead. Where can they better understand their remit and find support?

Do you like it?0
May 31, 2020

[FEATURED] MDR Or MDD: Which Route Should You Choose Now That The MDR Is Delayed?

With the recent EU decision to postpone the Medical Device Regulation by a year, what factors do medtech manufacturers need to consider when deciding the time to submit applications?

Do you like it?0
May 3, 2020

[FEATURED] Drug/Device Combinations: New Position Paper Explains Notified Body Responsibilities

Medicinal products authorities will consider a medtech notified body opinion on the device element of a drug/device combination product. A new position paper explains how roles and responsibilities are shared between medtech and medicinal product experts.

Do you like it?0
April 13, 2020

[FEATURED] European Commission Recommends Regulatory Midway For COVID-19 Products

The EU is addressing the regulatory obstacles that threaten to reduce the speed at which vital products needed to treat COVID-19 are produced.

Do you like it?0