14 search results
You searched for these word(s): risk assessmentCommittee for safety assessment of food contact materials (CBVV)
https://www.rivm.nl/en/food-contact-materials/CBVV… The Dutch Committee for safety assessment of food contact materials (CBVV) is the successor … of materials coming into contact with food. Based on this assessment, the CBVV gives an opinion on the proposed entry … in the dossier, and presents the outcome of the safety assessment in an opinion document. This document then serves …
Publication date: 11-04-2022MEBI: risk of serious health complaints from Rebound HRD® inguinal hernia mesh
https://www.rivm.nl/en/news/mebi-risk-of-serious-health-complaints-from-rebound-hrdr-inguinal-hernia-mesh… body for a long time, MEBI estimates there is a significant risk of other Rebound HRD® implants breaking in the longer … implants) to MEBI via the following website: rivm.nl/mebi . Risk of metal ring breaking An inguinal hernia mesh normally … for such a long time, MEBI estimates there is a significant risk of the metal wire breaking during the lifespan of the …
Publication date: 06-25-2024Shortcomings in the technical documentation of mesh implants intended to treat pelvic organ prolapse used in the Netherlands
https://www.rivm.nl/en/news/shortcomings-in-technical-documentation-of-mesh-implants-intended-to-treat-pelvic-organ… After a detailed assessment of the technical documentation of nine different … are used to treat patients with pelvic organ prolapse. The assessment was commissioned by the Dutch Health and Youth … the technical documentation. This took place after the RIVM assessment had been completed. Some of the manufacturers …
Publication date: 03-21-2022Mesh implants intended to treat pelvic organ prolapse
https://www.rivm.nl/en/news/mesh-implants-intended-to-treat-pelvic-organ-prolapse… examining mesh implants in the laboratory. Technical file assessment Serious complications can occur upon transvaginal … prolapse. Therefore RIVM prioritized the technical file assessment of two transvaginal mesh implants that were still … the product, it means there are uncertainties about the risks. The manufacturers have been given the opportunity to …
Publication date: 02-18-2020Gastric balloons
https://www.rivm.nl/en/medical-devices/gastric-balloons… causes the patient to eat less and lose weight. There are risks associated with the use of gastric balloons. RIVM has studied whether scientific research identified risks that are not currently stated on the instructions for … There are risks associated with the use of gastric balloons. The …
Publication date: 09-19-2024Injection needles
https://www.rivm.nl/en/medical-devices/injection-needles… residues. RIVM investigated whether patients’ health was at risk through the use of these needles. …
Publication date: 07-12-2017Summary International Expert Meeting on breast implant-associated lymphoma
https://www.rivm.nl/en/news/summary-international-expert-meeting-on-breast-implant-associated-lymphoma… 2018, Dutch research was published that found an increased risk for ALCL in women with breast implants. ALCL is short …
Publication date: 01-31-2019Food contact materials
https://www.rivm.nl/en/food-contact-materials… European Food Safety Authority (EFSA) will carry out the assessment. For substances in materials that are not … via European legislation, a dossier may be submitted for assessment in one or more EU Member States that keep a … in the Netherlands, the Dutch Committee for safety assessment of food contact materials (CBVV) will carry out …
Publication date: 11-04-2022Process applicable after an application has been submitted
https://www.rivm.nl/en/food-contact-materials/submitting-application-for-authorisation-in-netherlands/process-applicable-submitted… to the secretariat of the Dutch Committee for safety assessment of food contact materials (CBVV), the applicant … submitted is either complete and, as such, eligible for assessment by the CBVV, or incomplete and that lacking … must be submitted before the dossier is eligible for assessment. The CBVV will need a minimum of six months to …
Publication date: 11-04-2022Mesh implants intended to treat pelvic organ prolapse
https://www.rivm.nl/en/medical-devices/mesh-implants-intended-to-treat-pelvic-organ-prolapse… were included in a report published by the IGJ (in Dutch). Assessment of technical documentation The IGJ commissioned … implants. Therefore, as a first step, RIVM completed its assessment of the technical documentation for the two … decided to share the results – provisional pending the full assessment of all selected mesh implants – directly with the …
Publication date: 02-18-2020Submitting an application for authorisation in the Netherlands
https://www.rivm.nl/en/food-contact-materials/submitting-application-for-authorisation-in-netherlands… dossier can be submitted to the Dutch Committee for safety assessment of food contact materials (CBVV), provided the …
Publication date: 11-04-2022Information requirements for an application for authorisation
https://www.rivm.nl/en/food-contact-materials/submitting-application-for-authorisation-in-netherlands/Information-requirements… For the Preparation of an Application for the Safety Assessment of a Substance to be used in Plastic Food Contact …
Publication date: 11-04-2022Silicone breast implants
https://www.rivm.nl/en/medical-devices/silicone-breast-implants… Breast implants and the risk of BIA-ALCL ALCL is a very rare form of lymphoma. Women … breast implants with a rough surface present an increased risk of BIA-ALCL. The Dutch Health and Youth Care …
Publication date: 07-12-2017Breast implants can cause health problems even five years or more after placement
https://www.rivm.nl/en/news/breast-implants-can-cause-health-problems-even-five-years-or-more-after-placement… breast cancer and/or preventive removal due to genetic risk of breast cancer. Nature and number of health problems …
Publication date: 05-25-2023