If you are failing to plan, you are planning to fail.
It is crucial for all medical device manufacturers, as part of their business strategy, to concentrate on accessing their product portfolios and prepare a plan for the timely transition to the MDR. There are also limitations that needs to be considered when choosing to commercially distribute legacy medical devices under the old regulatory framework of the MDD. Importantly, there must be no significant changes – including labeling and packaging changes, if certification is achieved under MDD. Manufacturers should recognize that not all design changes are foreseeable or predictable and could likely require recertification to the MDR. Labeling and packaging changes are frequent changes that may result in MDR recertification.
Take the time a do a thorough MDD-to-MDR gap analysis
Conducting a detailed analysis regarding the new MDR requirements is imperative. For instance, a change relative to the classification generally implies extra documentation requirements such as literature research, an additional clinical investigation, and a comprehensive risk management review. Existing design dossiers or technical files must be up to date with the additional mandated requirements New application files submitted to the Notified Body after the MDR effective date must meet current MDR requirements along with quality system certification to the new MDR.Also, additional clinical data may be mandatory depending on the status of the current product portfolios, so include the planning and implementation in your timeline.
Toward the early 2021, maintenance of the documentation to the MDR standards will be mandatory. Products that remained certified to MDD will also need to be recertified to MDR at this timepoint.
Important MDD-to-MDR transition dates
The new European MDR began a 3-year transition period in May 2017. Below are some of We provide some key deadlines here and if you are planning your EU MDR transition timeline strategy, and you need help deciphering the requirements, we can conduct a comprehensive EU MDR gap analysis and help you formulate a clear EU MDR Strategy.
Let us help you make a smooth transition to the EU MDR. Contact us today for a proposal or more information.