European regulations are implemented to ensure the safety and efficacy of medical devices, they also assist in ensuring that there is access to the devices on the European market. New regulations have been put in place to increase the quality and safety of the devices that are available to us. Medical devices are extremely important to the EU, it’s crucial that the devices that are used are safe and work to the best of their ability. The aim of the new regulations is to increase simplicity, transparency and traceability. It’s so important to ensure that your medical device company is fully prepared for the changes. The new regulation was introduced in 2017, with a view to it being mandatory by the 26th of May 2020 for MDR and May 2022 for IVDR.
You must also apply the new regulations to your pre-existing devices. It doesn’t matter how long it’s been on the market for or how successful and safe you already know it is, you must include all devices within the new regulations. Manufacturers must do this according to MDR
EU 2017/745 for Medical Devices or to IVDR EU 2017/746 for In vitro diagnostic
Along with making obligations for manufacturer’s tighter, they’ve also increased the scrutiny of Notified Bodies by regulatory authorities. All Notified Bodies have been required to gain re-accreditation and partake in a range of other assessments.
The MDR has many benefits, including –
- Stricter rules at EU level.
- Aesthetic products included.
- New risk classification system.
- Increased traceability.
- Improved transparency due to Eudamed.
- Manufacturers can collect real-life data.
- Improved coordination within the EU.
It’s important to ensure that your medical device company adheres to all of the rules of the MDR and don’t forget that you must have it implemented by May 2020. If you need any more information, please don’t hesitate to get in touch.