Q&A on the Extension of the IVDR Transitional Periods has been Released
The EU Commission has released an informative Q&A document intended to provide guidance on the implementation of the extended transitional period provided for in the IVDR, as amended by Regulation (EU) 2024/1860 of 13 June 2024 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of EUDAMED, the obligation to inform in ...
UPDATE: MDCG 2020-16 rev.3 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746
There has been an update in the guidance document MDCG 2020-16 concerning the classification rules for in vitro diagnostic medical devices under regulation (EU) 2017/746. During this third revision, one can note there have been a few updates to this document. The most significant update is in the definitions section where there has been the ...
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 ...
Advena Updates Guidance Document Regarding (EU) 2024/1860
Following the publication of the amendment in the Official Journal of the EU, Advena has updated the guidance document that was published last month. The document was updated to make reference to an important date, the date of entry of the amendment, which is stated to be 9th of July 2024. This date is importantas ...
MDCG 2024-10 Clinical Evaluation of Orphan Medical Devices
The MDCG has released a guidance document concerning the Clinical Evaluation of Orphan Medical Devices. As defined in the guidance document, for a device to be considered an orphan device, it must be a medical device that is specifically intended to benefit patients in the treatment, diagnosis and prevention of a disease that presents in ...
MDCG 2024-1-5 Guidance on the vigilance system for CE-marked devices DSVG 05 Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence
The MDCG has released a guidance document on the on the vigilance system for CE-marked devices DSVG 05 Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence. This follows the same format of the vigilance guidance documents that were released earlier this year concerning Devices for Cardiac Ablation, Coronary Stents ...
MDCG Release Preliminary (re-)assessment review form templates for MDR and IVDR
The MDCG have released form templates relating to preliminary (re-)assessment of notified bodies. These templates are the following: The forms are relevant to assessing if the notified bodies meet the requirements to continue operating. There are different forms, concerning the different legislations, MDR and IVDR, and also forms depending on whether it is the first ...
UPDATE: MDCG 2022-4 Rev 2 Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD
There has been an update to the guidance document MDCG 2022-4 regarding the appropriate surveillance for legacy devices making use of the transitional provisions under Article 120 of the MDR. As one can expect the changes consists of adjustments all over the document to align it to Regulation (EU) 2023/607 of the European Parliament and ...
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 ...
MDCG 2024-5 guidance on content of the Investigator’s Brochure for clinical investigations of medical devices
The MDCG has released a guidance document concerning the content of the investigator’s brochure for clinical investigations of medical devices. For some background, when a sponsor of a clinical investigation submits an application in accordance with article 70(1) of the MDR, the application shall be accompanied by the documentation referred to in Annex XV, Chapter ...
