CE marking related to the registration medical devices in Europe.
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…
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…
EU MDR Post-market Surveillance System The European Medical Device Regulation 2017/745 requires establishing a post-market surveillance system once the medical device is on the market. The EU MDR Post-Market Surveillance requirements will be explained below: PMS system is established for the following: For each device: variants can be grouped for a device but the PMS…
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…
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’…
EU MDR clinical evaluation EU MDR clinical evaluation requirements are quite overwhelming. There are a lot of requirements and the strategy to achieve conformity is not always clear. We cover those requirements in detail. In order to show conformity with general requirements in terms of safety and performance to determine adverse effects and to evaluate…
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:…
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…
Medical Device Classification in the EU MDR One of the first concerns for manufacturers of medical devices attempting to sell their products on the European market is to decide what class is suitable for their products. The Medical Device classification in the EU MDR of the product can affect how and when the notified body…
EU MDR – Guide overview Below is a summary of different activities pertaining to the EU MDR (Europe Medical Device Regulation 2017/745). Compliance with EU MDR requirements is mandatory since May 26, 2021. Our summary includes the following sections: Summary of obligations from the manufacturer Summary of obligations of the manufacturer concerning his devices before…
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