EU Parliament Vote to Revise MDR and IVDR
The EU Parliament has adopted a resolution to revise the MDR and IVDR to address the ongoing challenges regarding implementation and support patient access to essential medical devices by 2025. The EU Parliament’s proposed amendments to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) are timely, balancing much-needed reform with a commitment ...
EU Publishes New Harmonised Standards for MDR and IVDR
To provide some context, a harmonized standard is a European standard developed by recognized European Standards Organizations such as: These standards are created based on a formal request from the European Commission. They are crucial for manufacturers, economic operators, and conformity assessment bodies, as they offer a recognized way to demonstrate compliance with relevant EU ...
Current State of Play for Medical Devices (MDR & IVDR)
We understand that the regulatory landscape of the MDR and IVDR is constantly changing, and in order to keep up to date with the changes, we have provided a current state of play with regards to some of the most important changes to the MDR and IVDR. MDR Extension Firstly, we would like to remind ...
EU Commission Release List of Notified Bodies with their Published Fees
In a significant move to promote transparency and fairness in the medical device market, the European Commission has released a comprehensive list of notified bodies along with their published fees for conformity assessments. This initiative is expected to bring much-needed clarity to the certification process, ensuring that manufacturers, particularly small and medium-sized enterprises (SMEs), can ...
UPDATE: MDCG 2021-5 Rev. 1 Guidance on standardisation for medical device
There has been an update in the guidance document MDCG 2021-5 concerning the standardisation for medical devices. The guidance document was initially released in 2021 to provide guidance on different aspects related to standards in the medical devices sector in support of the requirements laid down in the applicable EU legislation, taking into account its ...
Medical Device Definition under the MDR
As a manufacturer, it is vital to know whether your device is a medical device within the scope of the MDR as this would determine if the MDR applies to your device or not. You might think that a medical device is any product that is found in a hospital that is not a drug, ...
Gradual Rollout of EUDAMED Roadmap Published
The EU Commission has published a roadmap to illustrate the current planning for the gradual roll-out of EUDAMED. This roadmap is intended to give the relevant actors estimated timeframes of when each module will become mandatory for use. According to the roadmap published, the notice for the Actor, UDI/Devices, NB & Certificates and Market Surveillance ...
State-of-the-Art in Clinical Evaluation Reports
In accordance with the Medical Device Regulation, manufactures must show that devices are safe and perform as intended, taking into account the generally acknowledged ‘state of the art’. This term can also be found in the MEDDEV 2.7/1 rev 4 guidance, which guidance also demands that the manufacturer presents a thorough description of the state ...
Two New Notified Bodies have been Designated for MDR
April sees the addition of two new notified bodies designated under the Regulation (EU) 2017/745 (MDR). The notified bodies are from Denmark and France and are listed below: NB 2443: TÜV SÜD Danmark NB 0333: AFNOR Certification These new additions bring the total number of notified bodies designated under the MDR to 46. More information ...
Two Commission Implementing Decisions with References of Harmonised Standards Have Been Published.
On March 8th 2024 the EU Commission published in the Official Journal of the European Union (OJEU) two Commission implementing decisions concerning new references of harmonised standards in support of Regulation (EU) 2017/745 on medical devices (MDR) and of Regulation (EU) 2017/746 (IVDR). For the MDR: Commission Implementing Decision (EU) 2024/815 of 6 March 2024, ...
