The RAPS store will be under maintenance Saturday, 17 April between 5 AM and 12 PM EST. Store functionality may be unavailable at times during this window.
We apologize for any inconvenience caused during this time.

  • Regulatory NewsRegulatory News

    EC Offers MDR Guidance on New Safety and Clinical Performance Summary

    The European Commission’s Medical Device Coordination Group recently released guidance to help manufacturers create a new summary of safety and clinical performance (SSCP), as required by the EU’s Medical Devices Regulation (MDR) for implantable devices and for class III devices that are not custom-made or investigational. The SSCP, which will be validated by a notified body (NB) and made publicly available via the EU database on devices known as Eudamed, is expected to...
  • Regulatory NewsRegulatory News

    TÜV Rheinland Becomes 5th Notified Body Designated Under MDR

    The European Commission on Thursday announced that Germany’s TÜV Rheinland is the fifth notified body (NB) to be designated under the EU’s Medical Devices Regulation (MDR). A TÜV Rheinland spokesperson told Focus that beginning tomorrow, "we are accepting applications under MDR. We have also applied under IVDR [in vitro diagnostic regulation]. Our JAT [joint assessment team] audit under IVDR is scheduled to be during the first week of December and we expect to have ou...
  • 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...
  • Regulatory NewsRegulatory News

    EC Adds IMQ as Fourth Notified Body Designated Under MDR

    The European Commission (EC) on Tuesday added Milan, Italy-based IMQ Istituto to its list of notified bodies (NBs) designated under the new Medical Devices Regulation (MDR). The announcement does not come as a surprise, as Italy’s Ministry of Health announced in late July that IMQ met the requirements of the regulation. The EC had also previously indicated in its rolling plan,  updated last Monday , that four NBs have been designated. The other three NBs to be de...
  • Regulatory NewsRegulatory News

    EC Designates Third Notified Body Under MDR

    The European Commission announced on Wednesday that Germany-based Dekra Certification GmbH is the third notified body (NB) to be designated under the Medical Devices Regulation (MDR). Dekra joins Germany-based TÜV SÜD  and BSI UK as the only NBs to be designated and listed in the European Commission’s New Approach Notified and Designated Organisations (NANDO) database. A fourth NB is expected to be announced soon, as the MDR/IVDR implementation rolling plan, updated...
  • Regulatory NewsRegulatory News

    US and EU Fully Implement Mutual Agreement on GMP Inspections

    The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) on Friday said they have now fully implemented a plan that will allow member state regulators and FDA to mutually rely on each other’s good manufacturing practice (GMP) inspections of drug facilities. In addition to helping reduce redundancies in manufacturing inspections, the implementation of the Mutual Recognition Agreement (MRA) means that beginning Friday, pharmaceutical companies can sto...
  • Regulatory NewsRegulatory News

    EC Offers Two New Guidance Documents on MDR/IVDR

    The European Commission (EC) on Monday released one new guidance on persons responsible for regulatory compliance under the Medical Device Regulation (MDR) and the in vitro Diagnostic Device Regulation (IVDR), and another guidance on the implant card required by MDR. Under Article 15 of MDR and IVDR, companies are required to have at least one employee responsible for regulatory compliance with a degree in law, medicine, pharmacy, engineering or another relevant scien...
  • Regulatory NewsRegulatory News

    EU Begins Transition to Electronic Product Information for Medicines

    The European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medicines Agency (HMA) on Thursday launched a six-month public consultation on the draft key principles that will form the basis for creating electronic product information (ePI) for medicines in the EU. Derived from conversations with EMA, EC, HMA and various stakeholders, the draft key principles explain how ePI, which includes the package leaflet for patients and the summary of product...
  • Regulatory NewsRegulatory News

    European Commission Consults on Orphan Drug Applications

    The European Commission on Tuesday launched a targeted consultation to provide input on a revision of its guideline on the content and format of applications for orphan drug designation, as well as the transfer of designations between sponsors.   "The comments received will be taken into account by the European Commission in the finalization of the guideline on the format and content of application for designation as orphan medicinal products and on the transfer of des...
  • Regulatory NewsRegulatory News

    European Commission Focuses New Report on Pharma Competition Enforcement

    The European Commission (EC) on Monday released a report on pharmaceutical competition enforcement activities by the Commission and EU member states' national competition authorities from 2009 to 2017.   The 46-page report was put together in response to concerns voiced by the European Council and Parliament in 2016 and 2017 regarding anticompetitive practices within the pharmaceutical sector, such as tactics to delay generic competition, pay-for-delay arrangements...
  • Regulatory NewsRegulatory News

    European Commission Updates Q&A on Safety Features for Medicinal Products

    The European Commission recently released an updated document setting out nine new and one revised frequently asked questions and answers on the implementation of the rules on the safety features for medicinal products for human use. Building off a previous update in November , five of the new questions deal with general issues, like whether medicinal products can carry more than one batch number, or whether during the transitional period manufacturers located in the E...