EU Creates Expert Panels to Review MDR Implementation
The European Commission is creating expert panels to review the implementation process for the EU’s new medical device and in vitro diagnostics regulations after numerous industry groups have sounded alarms over the delay in implementing the new regulations.
With less than one year to go for devices to meet the May 26, 2020 implementation date —IVDs have until May 26, 2022 — the expert panels will assess high-risk devices and “contribute to the prospective improvement of the overall framework” by advising the Commission, the Medical Device Coordination Group, EU member states, notified bodies and manufacturers.
The panels will also take on other tasks such as contributing to the development of common specifications for clinical evaluation of device categories, guidance documents and standards. Experts on the panels will be appointed for three-year renewable terms.
Read the notice here: www.fdanews.com/07-05-19-ECMDIVD.pdf.
Canada Proposes New Device Regs to Improve Safety
Health Canada has launched a new consultation on proposed regulations that could impose additional requirements on devicemakers to make their products safer.
Under the proposal, manufacturers could be required to conduct additional assessments and to provide additional analyses and post-market reviews of their products.
The proposal calls for manufacturers to prepare annual summary reports of all known adverse events, reported problems, incidents, risks, and to notify Health Canada if there has been any change to the risks and benefits of a product.
Comments on the new regulations are being accepted until Aug. 26. Read the proposal here: www.fdanews.com/07-05-19-CanadaGazette.pdf.