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  • Regulatory NewsRegulatory News

    FDA approves pooled sampling for COVID-19 test

    Pooled sampling of COVID-19 swab specimens is now allowed under a reissued emergency use authorization (EUA) for the Quest Diagnostics SARS-CoV-2 rRT-PCR test, the US Food and Drug Administration (FDA) announced on 18 July.   Under the reissued EUA, four samples may be processed together in a batch, reducing the number of tests run and using fewer testing supplies. If the pooled sample is negative, no more testing would be required. If the pooled sample is positive, th...
  • Regulatory NewsRegulatory News

    Fourth notified body designated under IVDR

    Germany’s TÜV SÜD Product Service GmbH Zertifizierstellen on Wednesday became the fourth notified body designated under the In Vitro Diagnostic Regulation (IVDR).   TÜV SÜD, Germany’s second notified body under the IVDR, joins Germany’s DEKRA Certification GmbH and BSI’s UK and Netherlands arms, BSI Assurance UK Ltd and BSI Group The Netherlands B.V.   The newly designated notified body will be a welcome addition for industry, as the number of notified bodies des...
  • Regulatory NewsRegulatory News

    Eudamed to Launch in 2022 for Both Devices and IVDs

    The European Commission recently concluded that its database of medical device information (Eudamed) will only be operational once all modules are fully functional and an independent audit has been conducted, so the commission has decided to launch the database simultaneously for both medical devices and in-vitro diagnostics together in May 2022. The two-year delay of the database for medical devices (the commission reiterated that date of application of the Medical Dev...
  • Regulatory NewsRegulatory News

    BSI UK Becomes Second NB Designated Under IVDR

    The European Commission on Monday updated its NANDO database to include BSI Assurance UK Ltd as the second notified body (NB) designated under the In Vitro Diagnostic Regulation (IVDR). BSI said it is the first NB to achieve full scope designation, which covers all devices for IVDR. "This includes several new categories of devices with specific characteristics that were not covered by the In Vitro Diagnostics Directive [IVDD] such as cancer tests, genetic tests, physiol...
  • Regulatory NewsRegulatory News

    MDR/IVDR Guidance: MDCG Explains What’s Coming

    The European Commission’s Medical Device Coordination Group (MDCG) on Friday unveiled its plans for releasing almost 50 future guidance documents related to the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR), with the bulk of the new guidance coming on the oversight of notified bodies (NBs) and clinical investigations and evaluation (CIE). The list also notes that much of the guidance will be endorsed by the MDCG later this year or in 202...
  • Regulatory NewsRegulatory News

    MDCG Updates Q&As on Requirements for Notified Bodies

    The European Commission’s Medical Device Coordination Group (MDCG) recently added about six pages worth of questions and answers (Q&As) to its document on requirements relating to notified bodies (NBs). The update to the document, which was first released in June , comes as five NBs have been designated under the Medical Device Regulation (MDR), while one NB has been designated under the In Vitro Diagnostic Regulation (IVDR). Most of the information related to o...
  • Regulatory NewsRegulatory News

    EC Unveils Designating Authority’s Final Assessment Form Under MDR, IVDR

    The European Commission’s Medical Device Coordination Group (MDCG) on Thursday released a final assessment form for authorities designating conformity assessment bodies (CABs) and notified bodies (NBs) under the EU Medical Devices Regulation (MDR), which takes effect next May, and the In Vitro Diagnostic Regulation (IVDR), which takes effect in May 2022. The form includes space to describe the assessment carried out by the designating authority and whether all correctiv...
  • Regulatory NewsRegulatory News

    Classifying Software Under MDR, IVDR: New Guidance From MDCG

    The European Commission’s Medical Device Coordination Group (MDCG) on Friday released guidance to help medical software manufacturers understand the criteria for the qualification of software under the new EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The guidance discusses certain types of software that would be classified under MDR or IVDR, such as software that can directly control a (hardware) medical device (e.g. radiotherapy treatm...
  • Regulatory NewsRegulatory News

    EC Unveils First Notified Body Designation Under IVDR

    The European Commission (EC) on Thursday revealed that Germany-based Dekra Certification GmbH is the first notified body (NB) to be designated under the EU’s In Vitro Diagnostic Regulation (IVDR), which takes effect in May 2022. The designation, which follows Dekra’s previous designation as the third NB under the Medical Devices Regulation (MDR) in August, comes as experts have warned that there may be a shortfall of IVDR-designated NBs . Similar concerns have been ...
  • Regulatory NewsRegulatory News

    27% Will be Compliant? Survey Highlights Lack of Readiness for EU MDR

    A new RAPS/KPMG survey of more than 200 medical device industry leaders found that only 27% said they will be fully compliant with the new EU Medical Devices Regulations (MDR) set to go into effect 26 May 2020. Almost half of respondents also said they will likely discontinue or withdraw medical devices from the market because of the new regulation, and about half also said they will leverage the MDR’s transitional provisions to continue to sell their current devices in...
  • Regulatory NewsRegulatory News

    EC Explains New MDR, IVDR Rules for Designating Expert Device Panels

    The European Commission (EC) on Wednesday published an implementing decision on how new medical device expert panels will be designated under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The panels will provide scientific, technical and clinical assistance to the EC, the Medical Device Coordination Group (MDCG), member states, notified bodies and device manufacturers. In particular, the implementing decision notes that notified bodies ...
  • Regulatory NewsRegulatory News

    EC Names New Health Commissioner as Pharmaceutical and Device Units Shift to DG Sante

    European Commission President-elect Ursula von der Leyen unveiled her new team of commissioners-designate this week, including the addition of Stella Kyriakides, a medical psychologist from Cyprus, to lead the health portfolio. Moving forward, Kyriakides’s leadership will be crucial in the implementation of the EU Medical Devices Regulation (MDR), which has a looming implementation deadline next May, and the In Vitro Diagnostics Regulation (IVDR), which has an implement...