An optimally engineered and collaborative regulatory operations workplace is not a nice to have, but essential for organisational survival and success.
Let’s say I am a medical device importer or distributor and have just begun to think about how to incorporate MDR Article 14 and applicable EUDAMED requirements into my day to day processes, when the regulatory manager at manufacturing company AXV asks me about compliance to MDR Article 16 “Cases in which obligations of manufacturers apply to importers, distributors or other persons”.
Do you currently support your lead revenue generating, life-enhancing product with a collection of bench studies from 20 years ago? Can you effectively follow the history of the product data from when it was called project Heart to Heart3, then on to Tech4567 and finally PaceMaker Elite Mach 76A with titanium? We all know that […]
Regulatory change strategy may be defined as “the comprehensive elucidation of a project designed to achieve a specific regulatory goal, such as to obtain a new approval or clearance of an amendment.”
If a syringe without content is regulated as a device then why would prefilling the device with a drug change its regulatory requirements for registration/approval?
Can you identify your critical suppliers, link each to their respective product codes and registration status? Many medical device regulatory affairs teams struggle to connect these dots.
The EUDAMED database and related compliance activities may be implemented earlier than previously expected. Now is the time for regulatory operations teams to engage with their cross-functional colleagues to determine when and how they will implement the regulatory data requirements within their business.
Everyone, especially senior regulatory executives, has a preference for communication styles. Does your line manager request a departmental update via a one-hour presentation with lots of colourful graphics, an email composed of <200 words or a 10-minute telephone call? Regulatory professionals spend enough time justifying their role without supplementing any negative perception by presenting information to key stakeholders utilising the wrong approach……
Attention all manufacturers. Are you aware that if an Economic Operator (EO) considers your medical device to not be in conformity with MDR requirements, they are obligated to inform the competent authorities, thus impeding progress of your supply chain channels? The European medical device regulation places more direct responsibility on individual entities in the medical […]
Please be advised that on the same day of this original blog posting, 24 April 2020, the MHRA amended the “Medical Devices: EU regulations for MDR and IVDR” which finally provided an official UK update on the delay to full implementation. The details may be found at https://www.gov.uk/guidance/medical-devices-eu-regulations-for-mdr-and-ivdr The European Parliament, with its infinite wisdom, […]