There are published guidance documents including checklists on how medical device manufacturers can demonstrate cybersecurity compliance. Checking your devices against these guidelines can help you prepare your technical files for submission and auditing.
The MDCG has released a revised document, MDCG 2022-4 Rev 2, Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD. This guidance document outlines the activities to be performed by notified bodies as part of the appropriate surveillance defined in Article 120(3e) MDR.
There’s a new updated standard, (EN) ISO 17665:2024, sterilization of healthcare products using moist heat. This document provides requirements for the development, validation, and routine control of moist heat sterilization processes for medical devices. Of course it includes Annex ZA, relationship between the standard and the GSPR requirements of the MDR 2017/745. This sterilization method is primarily used in hospitals, including CSSD Departments, for the sterilization and re-sterilization of medical devices consisting of hard polymers and metals such as PEEK, Titanium and stainless steel. It will also be used for the upcoming EU new classification, class Ir, for the re-sterilization of reusable surgical instruments.
According to the official journal of the European Union (the Blue Guide) C 247, section 3.3, importers have important and clearly defined responsibilities under Union Harmonisation legislation. To a large extent, importers build on the type of responsibilities which a manufacturer based in the EU is subjected to and the importer must ensure that the manufacturer has correctly fulfilled his obligations.
Time is running out to qualify for the EU MDR transition extension as per the regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746. Manufacturers must apply for MDR certification with an MDR notified body by 26 May 2024 and before their MDD certificate expires. For new TGA ARTG entries, evidence must be submitted as part of the application. Contact us for more information.
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: [email protected] 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.
