What is the new EU MDR

EU MDR

What is the new EU MDR? Everything you need to know The European Union (EU) Medical Device Regulation is the latest step in regulating medical devices in the European Union and has been developed to strengthen the monitoring of the medical devices on the market and their manufacturers. The EU MDR has been enforced by…

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EU MDR standards

EU MDR harmonized standards

EU MDR harmonized standards first set released The manufacturer must justify and document the design steps of his device. He must verify compliance with the requirements of Annex I to the European Medical Device Regulation 2017/745 dedicated to general safety and performance requirements. EU MDR harmonized standards and reference requirements can be used for that…

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510k

510k

FDA 510k: Everything you need to know about preparing a premarket submission for medical devices A 501k is a device classification that allows manufacturers to sell their products without first obtaining approval from the FDA, but only if they meet specific criteria. That is, an FDA 510k submission is the technical documentation required by the…

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EU MDR Technical Documentation

EU MDR Technical Documentation

EU MDR Technical Documentation Summary The European Medical Device Regulation 2017/745 requires the compilation of technical documentation. See below a summary of the information to be included to comply with EU MDR Technical Documentation. The manufacturer shall develop technical documentation for each of its devices[1]. The technical documentation must be such that it allows the…

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EU MDR UDI

EU MDR UDI

Definition of UDI from the MDR EU MDR UDI has been introduced and even though it may not be new for those selling medical devices in USA, it is a new requirement to achieve the CE marking of a medical device. The European Medical Device Regulation 2017/745 defines the UDI as follow: (15)‘Unique Device Identifier’…

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EU MDR risk management

EU MDR risk management

EU MDR risk management EU MDR risk management requirements can be implemented with the help of the harmonized standard EN ISO 14971. The manufacturer must ensure risk management activities are carried out. He must update it periodically and systematically throughout the life cycle of each device[1]. In order to ensure risk management, the manufacturer must:…

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EU MDR standards

EU MDR standards

EU MDR standards The manufacturer must justify and document the design steps of his device. He must verify compliance with the requirements of Annex I to the European Medical Device Regulation 2017/745 dedicated to general safety and performance requirements. EU MDR standards and reference requirements can be used for that purpose. The manufacturer may benefit…

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