NAMSA is the World’s leading medtech cro offering global end-to-end development services
DRIVEN BY ITS GLOBAL REGULATORY EXPERTISE AND IN-DEPTH THERAPEUTIC KNOWLEDGE
FROM CONCEPT TO POST-MARKET, DELIVERING SIGNIFICANT TIME SAVINGS COMPARED TO INDUSTRY AVERAGES
HELPING medical device SPONSORS IMPROVE HEALTHCARE SINCE 1967
Driven by our global regulatory expertise and in-depth therapeutic knowledge, NAMSA is a medical CRO offering only the most proven solutions to move your medical device through the development lifecycle as efficiently and cost-effectively as possible.
As a medical contract research organization, we are dedicated to helping you achieve accelerated, successful development and commercialization outcomes. NAMSA’s offerings include medical device testing; regulatory, reimbursement and quality consulting; and clinical research services.
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Always on the pulse of industry news, we interpret the latest regulatory guidelines and other medical device updates so you don’t have to. Learn from the world’s most trusted medical device CRO to stay up-to-date on recent news and what it means for your medical device development plans and commercial operations.
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).
Navigating the 510(k) EO Sterility Change Master File Program
In May 2022, the FDA announced the 510(k) Sterility Change Master File Pilot Program in the Federal Register. Under the Pilot Program, the sterilization provider compiles and submits a Master File to FDA and, in the event the MAF is accepted and the 510(k) holder is granted a right of reference to the MAF, submission of a new 510(k) for the sterilization change may not be required.
New UK MHRA Medical Devices Regulations Published
On 26 June 2022, the United Kingdom’s Medical Devices and Healthcare Regulatory Authority (MHRA) published the results and conclusions from the consultation process regarding the new Medical Device Regulations for the UK. The final proposals contain comprehensive coverage of the various requirements to be included in the new UK Medical Device Regulations guidance. These new regulations are primarily based on EU Medical Device Regulation (MDR) 2017/745 requirements, but with significant differences in some key areas and new requirements surrounding new and innovative medical devices.
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”).
Let NAMSA’s medical device development experts guide you in the right direction.