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  • Feature ArticlesFeature Articles

    EU regulatory tools for RA professionals

    This article provides information on the key sources of information needed for understanding and keeping up-to-date with the European regulation of healthcare products, including medical devices and in vitro medical devices (IVDs), pharmaceuticals/medicinal products, and substances of human origin (blood, tissues, cells, and organs).   Introduction Regulatory professionals who need to understand the European regulation of healthcare products will find that the main s...
  • Feature ArticlesFeature Articles

    September’s Regulatory Focus: Countdown to EU MDR and IVDR

    Feature articles during September focused on aspects of the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), with articles on compliance and manufacturer obligations, and perspectives examining the current status of the regulations. The issue also included the second part of the cell and gene therapy series, and an article on regulatory tools for generic drug companies.   MDR and IVDR, close up Full implementation of MDR is slated for ne...
  • Feature ArticlesFeature Articles

    Implementing the MDR: Slowing down on the homestretch?

    With the most recent delay to 26 May 2021 as the date of application for the European Medical Device Regulation (MDR) 1 still fresh in our minds, 2 many wonder if it is a matter of time before we hear about the next extension. It’s a valid question, as many manufacturers still have a long way to go until they are fully compliant with the new rules and expectations. However, it does not do justice to the differences between the circumstances at the start of the first wave...
  • Feature ArticlesFeature Articles

    IVDR, notified bodies, and technical documentation: The devil is in the detail

    This article discusses notified body expectations for the technical file and provides some practical tips for preparing submissions.   Introduction The “devil is in the detail” is a phrase I’m using a lot these days, and it is a feature of the In Vitro Diagnostic Device Regulation (EU IVDR) 2017/746 1 that is tripping up IVD manufacturers as they make their first submissions.   The IVDR states in Annex II that:   The technical documentation and, if applicable...
  • Feature ArticlesFeature Articles

    MDR, IVDR, and compliance: A guide for distributors

    Distributors must prepare for new incoming requirements under EU medical device and in vitro diagnostic device regulations. The importance of establishing an effective quality management system, drafting comprehensive contractual agreements and, if required, engaging notified bodies, has created much uncertainty for distributors. To fulfil these new requirements and maintain device supply chains, it is essential for distributors to act early, ensure sufficient in-house com...
  • Feature ArticlesFeature Articles

    Manufacturer obligations applying to importers, distributors, or others under MDR and IVDR

    This article discusses issues and requirements spelled out in MDR and IVDR Chapter 2 and that chapter’s Article 16, which applies to manufacturer’s obligations and responsibilities. The author addresses new quality management system (QMS) requirements for repacking and translation of labeling, and the QMS certification obligations. Also covered are cases in which manufacturer obligations apply to importers, distributors, or other persons; changing a device’s intended purpo...
  • Regulatory NewsRegulatory News

    MDR/IVDR update: Experts share what keeps them up at night

    Speaking virtually at RAPS Convergence on Monday, top European medical device and in vitro diagnostic (IVD) experts shared what keeps them up at night as the date of application for both the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) approach.   With MDR delayed to May 2021, and with Eudamed’s full rollout and the IVDR date of application seemingly on track for May 2022, regulators, industry and notified bodies have much to prepare...
  • Regulatory NewsRegulatory News

    Eudamed actor registration module set to launch in December

    In a position paper released Tuesday, the European Commission’s Medical Device Coordination Group (MDCG) confirmed that the Eudamed actor registration module will be deployed on 1 December 2020.   The module was previously expected in May, but its deployment was pushed back by the Commission just before its launch date to reflect the postponed date of application of Eudamed. At the time, the Commission said it would pursue a phased rollout of the six Eudamed modules ...
  • Regulatory NewsRegulatory News

    MDCG explains how notified bodies can use MDSAP audit reports

    In a new guidance document, the European Commission’s Medical Device Coordination Group (MDCG) details how notified bodies can reference Medical Device Single Audit Program (MDSAP) audit reports when planning surveillance audits under the Medical Devices Regulation (MDR) or In Vitro Diagnostics Regulation (IVDR).   While MDSAP audit reports cannot be used to obviate the need for annual surveillance audits required under MDR/IVDR, MDCG says the reports can be used t...
  • 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...