Medical Devices Regulation (EU 2017/245) – Are you ready for 2020?
More than a year has passed since 25th May 2017 and the start of the three-year transition period from the Medical Devices Directive (93/42/EEC) and Directive 90/385/EEC on active implantable medical devices (AIMDD) to the Medical Devices Regulation (EU 2017/745).
But what does this mean for businesses with products currently on the market or a pipeline of new innovative medical devices? The answer every project manager likes to hear…it depends!
For most devices currently certified to the MDD the rules of device classification will not dramatically change, however transition planning should start now to allow enough time to assess if devices conform to the MDR and ensure they are not removed from the market.
How long do you have?
The first step to planning your transition to the MDR is to determine what key dates in the implementation of the MDR apply to your device or business.
What class is the device?
Device classification is also a key consideration when planning and budgeting for implementation of the new regulations. Although device classification has not drastically changed and still follows classification levels 1, 2a, 2b and 3 – some devices will be affected by re-classification or if currently not regulated as a medical device may now fall under the scope of AnnexXV1 of the MDR.
The greatest impact can be seen in the following device types:
• Class 1 devices containing software e.g. medical apps
• Class 1 devices that are currently self-certified, that have been reclassified to a higher classification
• Aesthetic or implantable devices without an intended medical purpose e.g. non-corrective contact lenses or equipment for liposuction
• Devices manufactured utilising non-viable human tissues or cells
• Class II implants if they come into contact with the spinal column
• Substance based medical devices
A change in device class can lead to new submission requirements including addition of essential requirements, update to Technical Files and Declaration of Conformity, and generation of clinical evidence, with all of these adding significant time and cost burden to a project. Therefore, it is essential that the classification of the device is established as early as possible to allow time for any unexpected activities.
Is your notified body designated?
Not only does the update to regulation extend the requirements of manufacturers, the notified bodies will also see significant changes to their responsibilities. And with the new classification rules the number of devices falling under the control of these notified bodies is significantly increased.
Re-designation of notified bodies is currently in progress to ensure there are enough notified bodies available by 2020 when regulations start to apply. At this point in time, in September 2018, no notified bodies are designated, although some have been assessed and are awaiting formal designation; therefore it is essential to check the status of your notified body and ensure they are able to support your device launch strategy.
With these key questions considered it may be time to put a plan in place or review existing project timelines.
To find out how CDP can help with your MDR transition, please get in touch.
Senior Consultant Quality Engineer