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Medical Device Single Audit Program (MDSAP), TGA, MDD, IVDD, MDR, IVDR and more………………………………

8 July 2024 gloizouUncategorized

Medical Device Single Audit Program (MDSAP), TGA, MDD, IVDD, MDR, IVDR and more……………………………… Achieve access to multiple markets with a single audit The International Medical Device Regulators Forum (IMDRF) established a working group to develop a standard set of requirements for auditing organizations (Certification Bodies) performing regulatory audits of Medical Device manufacturers’ quality management systems. Termed the Medical Device Single Audit Program (MDSAP), the requirements will be applicable to regulatory authorities, as well as third-party organizations that conduct such audits. What is MDSAP? The objective of the MDSAP is to develop, manage, and oversee a single audit program that will allow a single regulatory audit of a Medical Device manufacturer,[…]

C | M | S GONE GLOBAL

8 July 2024 gloizouTGA Sponsor

Need Australian TGA / European EU Rep / UK RP 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

Software as Medical Device (TGA)

8 July 2024 gloizouTGA Sponsor

The TGA transition period for software-based medical devices that met the regulatory changes set on 25 February 2021 ends on 1st November 2024. You will have until 1st November 2024 to apply for a conformity assessment with the TGA and to include your device in the ARTG list under the new, higher classification. Contact us to help you with this transition and to assist you with TGA conformity assessment.

Demonstrating cybersecurity compliance for your medical device.

5 July 2024 gloizouUncategorized

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.

MDCG revised document, MDCG 2022-4 Rev 2

18 June 2024 gloizouUncategorized

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.

EU MDR 2017/745

6 May 2024 gloizouUncategorized

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

Is your product Borderline or Boundary?

29 April 2024 gloizouUncategorized

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 your Medical Device

26 April 2024 gloizouUncategorized

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.

FDA Breakthrough Device Program

19 April 2024 gloizouUncategorized

The FDA Breakthrough Devices Program speeds up medical device development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization.

C | M | S GONE GLOBAL

19 April 202419 April 2024 gloizouUncategorized

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

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EU MDR 2017/745