Good morning dear followers! Yesterday, 11 September 2024, Team NB released the document: "TRANSFER AGREEMENT FOR SURVEILLANCE OF LEGACY DEVICES- specifying the terms of the transfer of the appropriate surveillance activities according to Article 110 (3e) of Regulation (EU) 2017/746 in respect of legacy devices covered by a certificate issued in accordance with Directive 98/79/EC". This document provides that a valid certificate under Directive 98/79/EC, issued by the "OUTGOING" NB, continues to be valid in accordance with paragraph 2 of Article 110 of Regulation (EU) 2017/746, i.e. where there is a written agreement with an NB, and that the manufacturer is subject to appropriate surveillance activities with respect to the applicable requirements under Article 110 (3e) of Regulation (EU) 2017/746 by the NB INCOMING. Appropriate surveillance may include, for example, examination of documentation, audits or other types of assessments carried out by a notified body in relation to a pre-existing device under the previous conformity assessment procedure of the CERTIFICATION HOLDER under Directive 98/79/EC. The agreed date on which the review activities by the INCOMING NB in accordance with § 4 of the TRANSFER AGREEMENT are to be completed and as of which the surveillance activities by the INCOMING NB are to be performed and the responsibility for appropriate surveillance assumed by the INCOMING NB is hereafter referred to as the ‘TRANSFER DATE’ and is specified in Appendix 1. The TRANSFER DATE shall not exceed 26 September 2025. The written agreement referred to above, specifies the terms and modalities for the transfer of appropriate oversight from an OUTGOING NB to an INCOMING NB in accordance with Regulation (EU) 2017/746 and other relevant scheme requirements set out at the end of this Agreement (see the section ‘Overview of Provisions Covered or Taken into Consideration in this Agreement’) and ensures the continuity of appropriate oversight activities between the OUTGOING NB and the INCOMING NB in accordance with such requirements. Source: https://lnkd.in/dgKsmkf #ivdd #ivdr #ivd #OUTGOINGNB #INCOMINGNB #TRANSFERAGREEMENT #legacydevices #qualityassurance #regulatoryaffairs #vlfconsulting
Velferd srl’s Post
More Relevant Posts
-
The countdown is well and truly on. We are seeing a proliferation of firms touting solutions and capabilties doing the rounds here in the region, but there is really only one firm that is credible in this space. We have been at it the longest and do it the best, so if you are grappling with how you will manage the changes coming to ASIC and MAS OTC Derivative Reporting this year, make sure you attend our Webinar to hear from the source!
Join our subject matter experts on Wednesday, 3 April at DTCC #RDS APAC Virtual Forum to find out how you can better prepare for the upcoming APAC Regulatory Rewrites. Register today: https://okt.to/QSeXJL
-
-
Long-anticipated final rule on AVMs adds to evolving regulations for model/algorithm development and use. Find out the five quality control factors that regulators will expect from institutions. #KPMGRegulatoryAlert #AVM #Regulatory https://dy.si/PgnbjR2
-
-
Long-anticipated final rule on AVMs adds to evolving regulations for model/algorithm development and use. Find out the five quality control factors that regulators will expect from institutions. #KPMGRegulatoryAlert #AVM #Regulatory https://dy.si/bEAqCS2
-
-
Experienced professional specializing in Deal Strategy and Execution. DEI and Mental Health Advocate
Long-anticipated final rule on AVMs adds to evolving regulations for model/algorithm development and use. Find out the five quality control factors that regulators will expect from institutions. #KPMGRegulatoryAlert #AVM #Regulatory https://dy.si/3endQC2
-
-
Based on last weeks TCB conference wanted to share some noted from SPEAG , on what was presented last week at the TCB Council Workshop in Baltimore. DASY8 is compatible with all new guidelines for SAR, APD, IPD including Module WPT V2.6 to be released next month. More information on the outcomes of the workshop is available here: https://lnkd.in/ebgV6pN8 hashtag #SAR hashtag #mmWave hashtag #compliancetesting hashtag #dosimetry hashtag #5G hashtag #TelecomSAR hashtag #SARTesting hashtag #WirelessCompliance hashtag #SafetyStandards hashtag #SARCompliance hashtag #RadiationSafety hashtag #RegulatoryCompliance Activate to view larger image, hashtag #SAR hashtag #mmWave hashtag #compliancetesting hashtag #dosimetry hashtag #5G hashtag #TelecomSAR hashtag #SARTesting hashtag #WirelessCompliance hashtag #SafetyStandards hashtag #SARCompliance hashtag #RadiationSafety hashtag #RegulatoryCompliance Activate to view larger image,
-
I attended the NDPC's Validation Workshop, organised yesterday, on the draft NDPA General Application and Implementation Directive (GAID). The workshop aimed to gather feedback from all relevant stakeholders on the draft GAID. Kudos to the NDPC 🙌 . It was a truly enriching event with thought-provoking feedback and concepts. I learned a lot and look forward to seeing the NDPC implement the suggestions and corrections raised. #data #dataprotection #regulatorycompliance
-
-
Long-anticipated final rule on AVMs adds to evolving regulations for model/algorithm development and use. Find out the five quality control factors that regulators will expect from institutions. #KPMGRegulatoryAlert #AVM #Regulatory https://dy.si/DM23cZ2
-
-
Long-anticipated final rule on AVMs adds to evolving regulations for model/algorithm development and use. Find out the five quality control factors that regulators will expect from institutions. #KPMGRegulatoryAlert #AVM #Regulatory https://dy.si/76qzoN
-
-
Long-anticipated final rule on AVMs adds to evolving regulations for model/algorithm development and use. Find out the five quality control factors that regulators will expect from institutions. #KPMGRegulatoryAlert #AVM #Regulatory https://dy.si/PeDZi
-
-
Long-anticipated final rule on AVMs adds to evolving regulations for model/algorithm development and use. Find out the five quality control factors that regulators will expect from institutions. #KPMGRegulatoryAlert #AVM #Regulatory https://dy.si/yqFEbA2
-
