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The IVD expert panel has provided new scientific advice on SARS-CoV-2. The advice highlights that while the virus can still cause serious illness, it no longer poses a life-threatening risk with a significant mortality rate for the general European population.  This information may affect how SARS-CoV-2 tests are classified under Regulation (EU) 2017/746. Manufacturers are encouraged to assess h..

The EU Regulations on medical devices and in vitro diagnostic medical devices MDR, IVDR1. Extension of MDR transitional period    - 31 Dec 2027: class III, class IIb implantable    - 31 Dec 2028: Other class IIb, class IIa, class I m/s 2. Extension of IVDR transitional period    - 31 Dec 2027: devices covered by IVDD certificate and class D    - 31 Dec 2028: class C     - 31 Dec 2029: class B, c..

This guidance, relating to the application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) addresses the classification of in vitro diagnostic medical devices (IVDs) and provides clarifications on the classification rules as set out under Annex VIII. This classification guidance also applies to diagnostic or information society services performed on EU patients or devic..

Even three weeks after the 2024 Hospitalar conference in Brazil, it is still worth highlighting some important points raised by Marcella de Abreu, GEVIT/ANVISA Manager, during her presentation covering the RDC 830/2023 legislation for in vitro diagnostic devices. This also serves as a reminder that RDC 830/2023 now applies to IVDs and products within the scope of IVDs in Brazil.Background on RDC..

SummaryOn July 16, 2024, the U.S. Food and Drug Administration (FDA) will host a webinar to discuss how in vitro diagnostic products (IVDs) are classified by the FDA.  If you have questions that you wish to submit for possible discussion during the webinar, please email CDRHWebinars@fda.hhs.gov. All questions must be received by June 28, 2024, to be considered for the discussion. Questions will ..

As previously reported by Emergo by UL, Brazilian medical device and IVD market regulator ANVISA has released three guidance documents to further clarify Resolution RDC 830/2023. Of interest to this post is the document regarding IVDs with a changed risk classification. The IVDs are presented in five tables: Class III to Class II, Class II to Class III, Class IV to III, Class II to IV, and Class..

▶ Introduction The Regulation (EU) 2017/745 on medical devices, hereafter referred to as the MDR, is applicable to the groups of products without an intended medical purpose that are listed in Annex XVI as from the date of application of the Commission Implementing Regulation (EU) 2022/2346, hereinafter referred to as the common specifications (CS). Products without an intended medical purpose t..

On November 30, 2023, the FDA announced in the Federal Register its intention to classify certain types of wound dressings that had remained unclassified as pre-amendment devices; i.e., devices that were in commercial distribution before enactment of the Medical Device Amendments of May 28, 1976. The specific wound dressings the FDA is proposing to classify fall into the following three distinct..

유럽연합에서 MDR과 IVDR하에서 borderline에 있는 제품의 적용여부와 관련된 문서 개정하여 배포하였다. ▶ 개정일자: 2023년 09월 27일 ▶ Version. 3 ▶ MDR borderlines: medical devices and IVDs medical devices and medicinal products, including advanced therapy medicinal products (ATMPs) medical devices and biocides medical devices and substances of human origin medical devices and cosmetic products medical devices and food medical devices and pe..