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MDR

Concept of MDR Medical Device Regulation.

UPDATE: MDCG 2022 – 5 Rev. 1 Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices

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There has been an update to the guidance document MDCG 2022-5 concerning guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices. The update includes the addition of products specifically intended for the cleaning, disinfection or sterilisation of medical devices in section 1.2.6.1 to the list of examples of … Read more

EU Publishes New Harmonised Standards for MDR and IVDR

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To provide some context, a harmonized standard is a European standard developed by recognized European Standards Organizations such as: These standards are created based on a formal request from the European Commission. They are crucial for manufacturers, economic operators, and conformity assessment bodies, as they offer a recognized way to demonstrate compliance with relevant EU … Read more

Concept of MDR Medical Device Regulation.

UPDATE: MDCG 2021-25 Rev. 1 Regulation (EU) 2017/745 – application of MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC

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There has been an update to the guidance document MDCG 2021-25 concerning the application of the MDR to legacy devices. To offer some background to this guidance document, the transitional provisions of Regulation (EU) 2017/745 on medical devices (MDR) have been revised by Regulation (EU) 2023/607. Notably, the transitional period has been extended to either … Read more

Concept of MDR Medical Device Regulation.

MDCG 2024-12 Corrective and preventive action (CAPA) plan assessment: guidance and templates for conformity assessment bodies, notified bodies, designating authorities and joint assessment teams

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The MDCG has released a guidance document concerning Corrective and preventive action (CAPA) plan assessment. This guidance document is designed for conformity assessment bodies (CABs), notified bodies (NBs), designating authorities (DAs), and Joint Assessment Teams (JATs) involved in the implementation of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro … Read more

Concept of MDR Medical Device Regulation.

New Notified body has been designated under MDR

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A new notified body has been designated for the MDR. The new notified body, NEOEMKI Nemzeti Orvostechnikai Eszköz Megfelelőségértékelő és Tanúsító Korlátolt Felelősségű Társaság (NEOEMKI LLC) (NB 1011), is based in Hungary. This new addition brings the total number of notified bodies designated under MDR to 50. More information on the notified body can be … Read more

Categories MDR
Concept of MDR Medical Device Regulation.

EU Commission Release List of Notified Bodies with their Published Fees

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In a significant move to promote transparency and fairness in the medical device market, the European Commission has released a comprehensive list of notified bodies along with their published fees for conformity assessments. This initiative is expected to bring much-needed clarity to the certification process, ensuring that manufacturers, particularly small and medium-sized enterprises (SMEs), can … Read more

Concept of MDR Medical Device Regulation.

Commission Implementing Decision (EU) 2024/2120 of 30 July 2024 renewing the designation of issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical device has been published in the OJEU

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At the end of July, the EU Commission implemented decision (EU) 2024/2120 regarding the renewal of issuing entities who are designated for the assignments of UDI (Unique Device Identifier) for medical devices. The regulation states that the issuing entities listed in the Annex of Decision (EU) 2019/939 will be renewed for the next 5 years … Read more

Concept of MDR Medical Device Regulation.

UPDATE: MDCG 2021-5 Rev. 1 Guidance on standardisation for medical device

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There has been an update in the guidance document MDCG 2021-5 concerning the standardisation for medical devices. The guidance document was initially released in 2021 to provide guidance on different aspects related to standards in the medical devices sector in support of the requirements laid down in the applicable EU legislation, taking into account its … Read more

Concept of MDR Medical Device Regulation.

MDCG 2024-10 Clinical Evaluation of Orphan Medical Devices

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The MDCG has released a guidance document concerning the Clinical Evaluation of Orphan Medical Devices. As defined in the guidance document, for a device to be considered an orphan device, it must be a medical device that is specifically intended to benefit patients in the treatment, diagnosis and prevention of a disease that presents in … Read more

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