A lot of buzz is going around EU MDR and it’s proposed transitional Deadlines. While these deadlines apply only to a certain Risk class of Medical Devices and do not apply to all Medical Manufacturers. Read about the details by clicking here
Irrespective of whether the proposal falls in place, Medical Manufacturers who are releasing the Gas pedal are making a big mistake. We have seen an increased delay in processing time to get a valid EU MDR certificate resulting in the Product going OFF the shelves. This disturbed supply chain negatively impacts the manufacturers and end users suffering due to the lack of availability of MedTech products. Manufacturers should consider this as the the right time to fuel in and get your RAQA sorted.
A Medical Device manufacturer should take the following steps:
- Stay informed: Keep up to date with the latest information and guidance from the European Medicines Agency (EMA) and other relevant authorities regarding the MDR and any additional delays or changes.
- Continue the transition process: Even though the deadline has been pushed back, manufacturers should continue working towards MDR compliance. This will ensure that they are ready when the new deadline arrives and avoid additional delays in getting their products to market.
- Review and update your Quality Management System (QMS) to ensure it aligns with the new regulation requirements.
- Review and update the Technical Documentation of your devices to comply with the new requirements.
- Review and update your Clinical evaluation and clinical data to comply with the new requirements.
- Appoint a EU Authorised Representative if you are a non-EU manufacturer.
- Get the device notified with the right notified body and get the devices certified as per the MDR requirements.
- Update labeling, instructions for use, and packaging to comply with the new requirements.
By following these steps, manufacturers can ensure that they are well-prepared for the new deadline and minimize any disruptions to their business.
Our Experts are working relentlessly to support all MedTech Manufacturers by providing End-To-End support. Connect with us by sending an email to mdd@mddltd.com
We are here to be your Regulatory Risk Partners for Medical Devices, Diagnostics and Digital Health!
This story was written by Medilink Midlands Member, Med Di Dia. To find out more about Medilink Midlands membership, click here.