MHRA published “Common Specification Requirements for In Vitro Diagnostic Devices” to seek views on the possible amendments to the Medical Device Regulations 2002. The goal is to include common specification requirements for manufacturers of high-risk IVD devices, similar to the current rules for List A IVDs under IVDD 98/79/EC.
The IMDRF published the final document ‘Principles of Labeling for Medical Devices and IVD Medical Devices’ on 26 April 2024. This document provides general labeling principles, including specific sections on the label, instructions for use, and information intended for the patient which can be used as guidance in meeting local regulatory requirements.
GOODBYE GMDN………………….HELLO EMDN The EMDN will be the nomenclature used when registering medical devices In the Eudamed database. Although mapped to the current GMDN Nomenclature, it is stand alone and will be used in future as a searching tool by EU Operators. SPEAK TO US TODAY George Loizou | Director | MDD/MDSAP/MDR Notified Body/AO Lead Auditor | MDD/MDR Notified Body Technical File Reviewer | Contact us on: C | M | S – Compliance Management Solutions – Leaders In Compliance (Australia, Europe, Vietnam, Singapore, Malaysia, NZ) M: +61 4 33 124266 W: compliancems.com.au E: gloizou@compliancems.com.au North Melbourne, Victoria
Under the MDR 2017/745, medical devices are classified into different classes based on their intended use and potential risks to patients. The MDR also includes additional requirements for certain devices, including borderline products.Borderline products are those that have characteristics of both medical devices and other products such as:– Borderline between medical devices and medicinal products,– Borderline between medical devices and substances of human origin– Borderline between medical devices and cosmetic products– Borderline between medical devices and personal protective equipment It’s important to understand the mode of action of the product to truly determine the regulatory framework. Incorrectly classifying a product can result in huge financial loss. In the case of borderline products, careful assessment[…]
Choosing the right Notified Body for certifying your medical device is important. Factors such as costs, Notified Body review times should be considered when making this decision. We work with many Notified Bodies across different device groups.
The FDA Breakthrough Devices Program speeds up medical device development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization.
CMS will be participating in Australia’s Medtech conference (AusMedtech 2024), which will be held on May 22-23 in Adelaide. Come talk to us at booth 13. George will also be chairing a panel discussion on EU Medical Device Regulations and how this has impacted the medical device market.
Need Australian TGA / European EU Rep or Asian Medical Device Representation? MEDICAL DEVICES LICENSE HOLDING / TGA SPONSORSHIP / EC REPRESENTATION Our latest service just launched and we’ve gone GLOBAL! Check out our website for more information and quotation. Compliance Management Solutions Melbourne, Australia (Head Office) E: gloizou@compliancems.com.au M: +61 433 124 266 W: https://compliancems.com.au
CMS can help you with your internal audit. Contact us to book your next internal audit. We are also hosting a three-day Auditor training session on May 14-16 2024. Contact us to book your spot.
The MDCG issued updated guidance MDCG 2024-3 on the content of clinical investigation plans for medical devices. It aims to assist sponsors with the CIP content and to pre-empt queries from regulatory authorities during application assessments. If you need help with your clinical evaluation, contact us.
