CE marking related to the registration medical devices in Europe.
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…
Medical Device Regulation date of application postponed The European medical device regulation 2017/745 have been postponed one year later in order to avoid shortages in getting key products available on the market during the coronavirus pandemic. The Medical Devices Regulation (MDR) which was initially enforceable on 26 May 2020 will now become fully effective on…
In January 2013 new Revision 8 of MEDDEV 2.12-1 about vigilance system in Europe was posted on the European commission webpage. The document itself can be found here. We’ll highlight below the changes that occured in the new guidance.
MEDDEV 2.7.1: clinical evaluation New Regulation on Clinical Evaluation One of the changes of the Medical Device Regulation by the European Commission is the compliance with clinical evaluation. This means that a report with an expert opinion of medical professionals about the quality and safety of the medical device will not be sufficient any longer.…
What happened before the EU Medical Device Regulation and In vitro Diagnostic Regulation ? See what changes in EU medical Device Regulation. The existing European regulatory framework originated in the 1990s consists of three directives designed to regulate about 500,000 types of medical devices (e.g. contact lenses, breast implants, x-ray machines, pacemakers) and in-vitro diagnostic…
The Notified Bodies Oversight Group (NBOG) has published (Nov. 2014) the following revised Notified Body guidance documents. The aim of such guidance is to address some of the best practice expected from manufacturers and Notified Bodies. The guidance documents can be found on the below link: 1. NBOG BPG 2014-3 – Guidance for manufacturers and…