9th February, 2022, will be the date when the IVD manufacturers will have to adjust their business from the requirements of IVD Directive to the IVD Regulation (EU) 2017/746. This regulation provides a modern regulatory framework to the operators of the IVD market, including suppliers that provide critical products such as raw material for the in vitro diagnostic medical devices.
At Rekom Biotech we are committed to make your way easier by guaranteeing that we meet the requirements of this regulation. On 9th July, 2021, Rekom Biotech obtained the ISO 13485 certification. According to the Commission Implementing decision (EU) 2020/439, this is one of the harmonized standards applicable for IVD medical devices indicated for meeting the essential requirements of the regulation.
The ISO 13485 is a standard for a quality management system (QMS) for designing and manufacturing of medical devices. This is the main QMS standard for medical devices in Europe, Canada, and Australia. It serves as the basis for QMS compliance in other countries such as Japan, Korea, and Brazil. For instance, the US plans to harmonize the FDA requirements for medical devices with ISO 13485.
We have also the ISO 9001 certification, a standard on which the ISO 13485 is based. ISO 9001 focuses on customer satisfaction and continuous improvement. ISO 13485 has additional medical device and safety requirements and greater documentation.
So do not worry! With us, you can rest assured that your raw material supplier complies with the Regulation, so you can focus on other, more important issues.