Things You Need to Know About the EU Medical Device Regulation in 2020

If you want to know what the EU Medical Device Regulation is all about, we will educate you with complete information in this article. Basically, the medical devices that have been designed and manufactured for the sole purpose of medical use by professionals need to be regulated by a national authority that ensures the safety of its users and promises delivering fair results as promised by the manufacturers. EU Medical Device Regulation  authority ensures that the medical devices that are made to pass through some tests and if they comply with the latest regulations then it ensures that the devices are of utmost quality and capable of delivering promised results.

Medical devices used in the EU have to pass through the conformity test that is conducted under the strict supervision of the concerned professionals that examine the devices minutely and declare them fit for usage only if they perform as intended.

The current medical device directive is soon going to be replaced by the EU’s medical device regulation in the coming year 2020. So, if you are manufacturer then your clock is already ticking as you have considerably less time to fully adapt to the recently approved medical devices and meet the latest requirements of the EU medical device regulation.

Here are a few things that you need to know about the Medical Device Regulations:

Heightened Risk Management Measures of Medical Devices

Now, with the implementation of the new refined rules and regulations, expected by May 2020,

manufacturers will have to present a detailed, in-depth data which will assure and check the boxes of quality, performance and safety.

The manufacturers will be required to report every little incident which leads to near-death experience, deaths and injuries into the EU portal as it would eventually help the authorities to keep a track record of the performance of one particular medical device. The past performance of a medical device will act as the key factor for framing the safety-related information for the buyers, patients and users. The safety information provided about the medical device helps create transparency with the patients. With the new medical device directive all the medical devices will largely classified on the basis of these two important factors which are as follows:

• Medical devices that come at a higher risk
• Surgical devices that can be reused

Now, with the implementation of the new refined rules and regulations, expected by May 2020, manufacturers will have to present a detailed, in-depth data which will assure and check the boxes of quality, performance and safety.

Compensation for damages caused due to the use of defective medical devices Now, the patients or the users can file for compensation if they had to suffer any damage or injury due to the use of a medical device. With the new MDR coming into force, the non-European manufacturers along with the authorized representatives will be held accountable for any harm or damage caused to a patient due to the use of medical equipment.

Re-assessment of the medical devices is mandatory with the new MDR

To make sure that the medical devices comply with the new MDR, all the devices are required to be reassessed before May 2020, and this has to be made sure that the medical devices comply with the latest certifications and requirements listed by the regulatory bodies.

Stringent rules and guidelines will pressurise all the competent authorities

As now heed would be paid to every minute detail so the European Union and the competent authorities will be under a lot of pressure. The processes including clinical checkups and certification will take a huge amount of time.

The medical device market could become one roller coaster ride! To walk through the grueling process of getting the medical devices re-accessed, get the latest certification there are many medical device regulatory consultancies that practice delivering supportive services. You can personally hire qualified medical devices consultants also termed as lead auditors that will help you get notified body audits.

We believe that we could help clear the cloud around the EU Medical Device Regulation!