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Future of Medical Compliance

Future of Medical Compliance

With 2020 just around the corner, it’s important to note that in May 2020, compliance with the Medical Device Directives will no longer be acceptable.

From May 2020, all medical equipment must adhere to the Medical Device Regulations (MDR) or the In Vitro Diagnostics Regulations (IVDR), in order to be placed on the EU marketplace. CE certification must also be obtained. MDR begins in 2020 and IVDR begins in 2022.

This new regulation has been created to ensure a higher level of safety for patients requiring each medical device. It will also address weaknesses revealed by the Medical Device Directives by some medical device manufacturers. The core elements of a device must be submitted to the Unique Device Identification (UDI) database, prior to being placed on the market. The device must have UDIs visible in order to increase traceability, as changes in name, packaging or models can cause confusion. The re-use of surgical devices will now be ‘Classed Ir’, rather than ‘Class I’, and will required to be certified by a Notified Body.

A Risk Management plan has been expected from manufacturers for years, but now it’s even more important. Under the new MDR, each device must have a documented risk management plan, and all foreseeable hazards must be revealed. Our experienced consultants can help with this.

The demand of Post Market Surveillance (PMS) will also increase. This entails reviewing the post market data of each device. MDR and IVDR outline that PMS is integrated into the quality management system.

At Patient Guard, our medical device regulatory consultants are qualified lead auditors to ISO 13485:2016 and qualified to act as ‘Qualified Persons’ in line with the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). We can offer assistance with all aspects of the new Medical Device Regulations. With over 40 years of combined experience, our highly trained professionals are always on hand to help.

Get in touch with Patient Guard today.

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