Final texts of the EU MDR & IVDR (R = Regulation) have been released recently and start their transition periods sometime in the early to mid 2nd quarter of 2017. The MDD has a 3 year transition period and the IVDR has a 5 year transition period. You should be starting your quality planning now if you haven’t already and start talking with your Notified Body to make sure they will still be notified for your specific type of device/technology as many Notified Bodies have lost their notifications and more are sure to fall or fail.The reason for this change from the MD & IVD Directives is because of the PIP Breast implant scandal and issues with implantable metal hips.
Some of the changes manufacturers will have to deal with include:
*Quality Management Systems
*Clinical Evidence Requirements
*Authorized Representatives Requirements and Liability
*You may need to change Notified Bodies if their scope changes during the designation process
*Need to prepare and implement for Unique Device Identifiers (UDI), starting with the highest risk class
*Person responsible for regulatory compliance in your company – minimum requirements
*Classification rules will change & some devices that are not considered medical device currently will fall under the MDR
*Classification rules will impact IVDs significantly under the IVDR
*Updates to post market surveillance & vigilance requirements
*Economic operators in the supply chain will have some changes to the obligations per the MDR or IVDR
Here are some resources to share with you:
greenlight.guru Webinars on How to Prepare for the New EU Medical Device Regulations (MDR) and How to Prepare for the New EU In Vitro Diagnostics Regulations (IVDR)
For the following 3 BSI White Papers* please select the title from the BSI White Paper webpage.
BSI’s white paper* on the MDR “Planning for implementation of the European Union Medical Devices Regulations – Are you prepared?”
BSI’s white paper* on the IVDR titled “How to prepare for and implement the upcoming IVDR – Dos and don’ts”
BSI’s white paper* on the MDR & IVDR draft text (article updated Oct 2015) titled “UPDATED: The proposed EU regulations for medical and in vitro diagnostic devices”
BSI webpage for white papers* has additional white papers on medical devices / IVDs and quality system requirements.
One of my favorite blogs to follow on the MDR changes is Erik Vollebregt’s Medicaldeviceslegal.com blog. Erik does an excellent job providing really great information on the subject and keeping his finger on the pulse of the issue at hand.
* Note, through out the BSI White paper series I have had the honor of being on the Advisory Panel to help shape the series and review each of the white papers to provide my years of experience in the medical device industry and the regulatory world.
De-notification of EU Notified Bodies under MDD
The number of EU Notified Bodies (NBs) under the MDD has dropped from about 80 to less than 60 because of the increasingly more stringent NB requirements. Are you sure your Notified Body scope still covers your products or are they de-notified? The French Competent Authority (National Agency for Safety of Medicines and Health Product [ANSM]) in late 2016 published an Information Bulletin.
Also, what is going to happen when the Notified Bodies apply for designation under the MDR and when will your Notified Body get approved for the designation under the MDR. The designation process may take a year or more and some NB’s may not get designated for all they expect or they may decide to shutter their doors, among other scenarios. So, make sure to read the notifications in the above paragraph and also stay in close contact with your NB to make sure you don’t get left in the cold without a proper NB for your product lines.
If you need help with your EU MDR or IVDR transition planning please email Leo Eisner at Leo at EisnerSafety dot com, or call Leo at +1 (503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants.