Author: OMC Medical

November Newsletter

EUROPE EUDAMED Notified Bodies and Certificates Module – Relevant documents and information| 15 November 2021 Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establish that Notified Bodies (NB) should register in EUDAMED any information regarding certificates issued (including amendments and supplements), suspended, reinstated, withdrawn or […]
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October Newsletter

EU REGULATIONS The expert panel in the field of in vitro diagnostic medical devices now accepts submissions from notified bodies for the Performance Evaluation Consultation Procedure | 14 October 2021 To prevent disruption in the supply of these essential healthcare products, the European Commission has proposed a progressive roll-out of the new In Vitro Diagnostic […]
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September Newsletter

EU REGULATIONS The expert panel in the field of in vitro diagnostic medical devices now accepts submissions from notified bodies for the Performance Evaluation Consultation Procedure | 03 September 2021 Regulations EU MDR 2017/745 on Medical Devices and EU IVDR 2017/746 on In Vitro Diagnostic Medical Devices contain important improvements among which stricter control for high-risk […]
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Labelling Requirements – Swiss Authorized Representative - www.omcmedical.com

Labelling Requirements – Swiss Authorized Representative

Who is a CH-REP? Swiss Authorized Representatives shall be referred to as CH-REP in accordance to the Medical Device Ordinance. Who needs to Appoint an AR? Any medical device manufacturer not based in Switzerland shall sell their products in the Swiss market only after a Switzerland based Authorized Representative is appointed. Where AR name has […]
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Romania Medical Device Registration

MEDICAL DEVICE REGISTRATION IN ROMANIA

How OMC Medical can assist you with the process Act as your Romanian AR    Help you with the Romanian registration by filling in the form and registering the medical device with the NAMMD authorities.   Translate your documents to Romanian for submission. Regulatory Authority: National Agency for Medicines and Medical Devices of Romania  Link for MoH: https://www.anm.ro/en/  Local Listing or Registration: Yes, Local listing is required.  Local […]
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August Newsletter

EU REGULATIONS Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | 20 August 2021 This guidance is intended to aid notified bodies to implement requirements established by MDR and IVDR about certification activities to be carried out according to Article […]
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July Newsletter

EU REGULATIONS MDCG 2021-23 – Guidance for notified bodies, distributors, and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746| 20 August 2021 Notified bodies providing certifications to certify that the quality management system of the distributor or importer complies with the requirements laid down in the […]
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June Newsletter

EU Regulations European Medical Device Nomenclature (EMDN) – Questions and Answers | 15 June 2021 European commission (MDCG) published a question and answers article for European Medical Device Nomenclature (EMDN). European Medical Device Nomenclature (EMDN) supports the functioning of the European database (EUDAMED). EMDN will be used for registration of medical device in EUDAMED by […]
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Swiss Manufacturer Obligations - www.omcmedical.com

Swiss Manufacturer Obligations

1. Manufacturers outside Switzerland will need to appoint Swiss AR. 2. The Manufacturer will use commercially reasonable efforts to update its technical documentation for the devices, to comply with the requirements of the ordinance, and to complete a conformity assessment procedure for devices in due time prior to the expiration of their current certificate of […]
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Switzerland AR Responsibilities - www.omcmedical.com

Switzerland AR Responsibilities

Obligations of the Swiss Authorised Representative 1. Verify the DoC and technical documentation have been drawn up and where necessary conformity assessment procedure has been carried out. 2. Keep available a copy of the technical documentation, the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, at […]
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