Navigating the Transition: Understanding the EU’s Proposed Amendments to IVDR
This blog delves into the recent amendments to the IVDR and how it will affect both transition timelines and requirements.
Category: IVD
Why IVD Developers Must Embrace the IVDR Transition Now
This blog delves into the crucial transition from the In Vitro Diagnostic Device Directive (IVDD) to the IVDR, highlighting the pressing need for developers to take immediate action.
European Parliament to Amend MDR/IVDR Transitional Provisions
On 16 February 2023, the European Parliament voted to adopt an amendment that affects Article 120 and Article 110 of Regulations (EU) 2017/745 and (EU) 2017/746, respectively. The amendment only extends the transitional period for legacy medical devices, but also removes the sell-off period for both medical and in vitro diagnostic (IVD) devices.
U.S. FDA Emergency Use Authorization: CRO Lessons Learned for the MedTech Industry
During the COVID-19 Pandemic, the FDA CDRH put the hardest, longest and most intensive work into reviewing EUA applications for COVID-19 diagnostic tests. The result was a shift in how the FDA, MedTech manufacturers and CROs conduct work, which is still in place today.
Monkeypox: Not all EUAs Are Created Equal
The FDA declared a public health emergency for monkeypox on August 4, 2022 and authorized EUAs for diagnostic tests as of September 7, 2022. For this latest policy, the FDA is inviting experienced test developers with high manufacturing capacity to notify the FDA of their intent to submit an EUA request by October 13, 2022.
MDCG 2022-10: Interfaces between the Clinical Trial Regulation and IVDR
Assays used in clinical trials may range from CE-marked IVDs to trial- or medicinal product-specific assays that are not always meant to be developed as IVDs. In order to assure that conformity is maintained on both the drug and device sides, MDCG—with the Clinical Trials Expert Group (CTG)—have published a Q&A document to clarify requirements for these assays.
MDCG 2022-3: Verification of Manufactured Class D IVDs in accordance to the IVDR—One Size Fits All?
One of the most compelling requirements in the IVDR EU regulation deals with two important aspects of conformity assessments of Class D IVD medical products: namely, the batch verification process and the involvement of EU reference laboratories that conduct these processes. In February 2022, a new guidance document was released by the Medical Devices Coordination Group (MDCG) that allows a more precise interpretation of these requirements: MDCG—Verification of Manufactured Class D IVDs by Notified Bodies.
The New UK MHRA Medical Device Regulations: Impact to IVD Manufacturers
Within this blog post, we will highlight IVD-specific issues, including areas of difference between the new MHRA regulations in contrast to EU regulations—and more specifically, the IVDR/MDR. We will also discuss new areas related to innovation/routes to the UK market and processes put in place to ensure that IVD devices are available on the UK market after the implementation date of the UKCA (1 July 2023).
MDCG 2022-8: Clarification of IVDR Requirements for Legacy Devices
The MDCG 2022-8 is probably one of the most important IVDR guidance documents that has been published in recent months as it finally clarifies what requirements are/are not applicable to legacy IVDs post-IVDR Date of Application (26 May 2022). This guidance discusses: 1) requirements within Chapter VII for post-market surveillance; 2) market surveillance/vigilance for “legacy devices”; 3) other IVDR requirements for “legacy devices”; and 4) IVDR requirements for devices placed on the market prior to 26 May 2022 (“old devices”).
MDCG 2022-2: Recommended Strategies for Data Retrieval and Literature Reviews
On January 27, 2022, MDCG 2022-2: “Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs)” was published. This document provides information for manufacturers, regulators, investigators, sponsors, Notified Bodies and other industry stakeholders concerning the continuous process for IVD performance evaluation.
MDCG 2022-6: Transitional Provision Considerations for IVDR Conformity
At the end of May, a new Medical Device Consortium Group (MDCG) document was published by the European Commission: MDCG 2022-6—“Guidance on Significant Changes Regarding the Transitional Provision under Article 110(3) of the IVDR.” This guidance covers important information regarding the implementation of EU Regulation 2017/746, also known as IVDR and discusses key areas such as timelines, as well as the background and purpose of MDCG 2022-6.
FDA Issues COVID-19 Transition Plans for EUA and Enforcement Actions
Following the declaration by DHS of the COVID-19 Pandemic, the FDA began to issue Emergency Use Authorization (EUA) approvals and enforcement policies for devices used to mitigate the spread of the SAR-CoV-2 virus, including the diagnosis, treatment or prevention of Coronavirus Disease (COVID-19). On, December 23, 2021, the Agency acknowledged the general need for a transition process back to ‘normal operations’ and released two draft guidance documents that introduce their proposed transition plans.
China State Council Releases Order 739, Creating New Market Access Opportunities for Global Medical Device and IVD Manufacturers
China’s top administrative authority, the PRC State Council, issued the new regulation of Supervision and Administration of Medical Devices (or State Council Order Number 739) on February 9, 2021.
MDCG Publishes New Guidance on Use of Standards Under MDR/IVDR
On April 16, 2021, the Medical Device Coordination Group (MDCG) published “Guidance on Standardisation for Medical Devices” (MDCG 2021-5).
New Guidance: Classification of IVD under the IVDR
On 13 November, the Medical Device Coordination Group (MDCG) published their long anticipated IVD Classification guidance document for IVDR (MDCG 2020-16). The purpose of the document, “is to provide guidance to manufacturers, notified bodies and health institutions on how to classify an IVD prior to placing it on the market, making available on the market or putting into service in the Union.
UKCA: A Wait and Watch Approach?
On 1 September 2020, the gov.uk website published a new guidance document for manufacturers that place medical devices on the British market. Specifically, this document provides guidance on securing the UK Conformity Assessed (UKCA) mark from January 2021 onward.
Key Considerations for Executing Clinical Trials for Dual 510(k) and CLIA Waiver Applications
With the number of COVID-19 cases on the rise, and no definite end date to nationwide travel restrictions, various Contract Research Organizations (CROs) and Biotech/Pharma companies are hard at work trying to figure out how to efficiently conduct ongoing clinical trials while employees work remotely and subjects are restricted to their homes. Virtual options for clinical trials are gaining more clinical industry leader and regulator attention at this unique time in history. With the current technological resources available, Sponsors are able to conduct certain IVD clinical trials virtually with full regulatory compliance to FDA guidelines, and with several advantages.
The IVDR Compliance Roadmap: From Start to Finish
With the number of COVID-19 cases on the rise, and no definite end date to nationwide travel restrictions, various Contract Research Organizations (CROs) and Biotech/Pharma companies are hard at work trying to figure out how to efficiently conduct ongoing clinical trials while employees work remotely and subjects are restricted to their homes. Virtual options for clinical trials are gaining more clinical industry leader and regulator attention at this unique time in history. With the current technological resources available, Sponsors are able to conduct certain IVD clinical trials virtually with full regulatory compliance to FDA guidelines, and with several advantages.
IVD Clinical Trials in the Era of COVID-19: Time to go Virtual?
With the number of COVID-19 cases on the rise, and no definite end date to nationwide travel restrictions, various Contract Research Organizations (CROs) and Biotech/Pharma companies are hard at work trying to figure out how to efficiently conduct ongoing clinical trials while employees work remotely and subjects are restricted to their homes. Virtual options for clinical trials are gaining more clinical industry leader and regulator attention at this unique time in history. With the current technological resources available, Sponsors are able to conduct certain IVD clinical trials virtually with full regulatory compliance to FDA guidelines, and with several advantages.
Diagnostic Developers Look to EUA Submission to Combat Novel Coronavirus (COVID-19)
China initiated its highest level of emergency response to the COVID-19 outbreak (also referred to as the novel Coronavirus) on 20 January 2020.
Key Requirements of Post-Market Surveillance under IVDR
As the new In Vitro Diagnostic Regulation (IVDR) replaces the current In Vitro Diagnostic Directive (IVDD) in 2022, there are many significant changes that IVD manufacturers must consider from a risk management perspective, as well as those pertaining to Post-Market Surveillance (PMS) to meet compliance.
IVDR Technical Documentation: 5 Critical Parameters of Change You Must Understand
The European Union’s In Vitro Diagnostic Regulation (IVDR) 2017/746), which replaces the current In Vitro Diagnostic Directive (IVDD 98/79/EC), introduces risk–based classification for IVD devices, in addition to new and required Technical Documentation. Specifically, the seven (7) classification rules under the IVDR have resulted in four (4) new risk groups for IVD products, which determine … Continued
Three Essentials for Smart IVD Clinical Trial Design
When designing an In Vitro Diagnostic (IVD) clinical trial, there are three major areas that must be considered if manufacturers are to achieve optimal, accurate outcomes: Biostatistics Clinical research conduct Data management While these three clinical research disciplines are interdependent on one other, equal attention should be paid to each of these functions, as outlined … Continued
NAMSA® Launches “Uniquely IVD” Development Services to Expedite in vitro Diagnostic Technology Commercialization Efforts for Global Manufacturers
TOLEDO, OHIO – (BUSINESS WIRE) – NAMSA®, the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated laboratory testing, clinical research and regulatory consulting services, announced today the launch of its in vitro diagnostic (IVD) development business to provide global manufacturers a proven resource for expedited commercialization outcomes delivered via NAMSA’s “Uniquely IVD” … Continued