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May Newsletter 2022

EUROPEAN UNION (EU) Stricter rules for placing medical tests on the market | 25 May 2022 From 26...

April Newsletter

AUSTRALIA Transitioning to the new Therapeutic Goods Advertising Code | 05 April 2022 The...

March Newsletter

AUSTRALIA Consumer/Patient information materials requirements | 02 March 2022 On 26 October 2017,...

February Newsletter

EU REGULATIONS MDCG 2022-4 - Guidance on appropriate surveillance regarding the transitional...

January Newsletter

EU Regulations MDCG 2022-1: Notice to 3rd country manufacturers of SARS-CoV-2 In vitro diagnostic...

December Newsletter

EU REGULATIONS MDCG 2022-4 - Guidance on appropriate surveillance regarding the transitional...

November Newsletter

EUROPE EUDAMED Notified Bodies and Certificates Module – Relevant documents and information| 15...

October Newsletter

EU REGULATIONS The expert panel in the field of in vitro diagnostic medical devices now accepts...

September Newsletter

EU REGULATIONS The expert panel in the field of in vitro diagnostic medical devices now accepts...

August Newsletter

EU REGULATIONS Guidance for notified bodies, distributors and importers on certification...

Importer

Cosmetic

Quality Management System Requirements of EU MDR

The quality management system shall cover all parts and elements of a manufacturer’s organisation dealing with the quality of processes, procedures, and devices. It shall govern the structure, responsibilities, procedures, processes, and management resources required to implement the principles and actions necessary to comply with EU MDR 2017/745.

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Regulations

Quality Management System Requirements of EU MDR

Quality Management System Requirements of EU MDR

The quality management system shall cover all parts and elements of a manufacturer’s organisation dealing with the quality of processes, procedures, and devices. It shall govern the structure, responsibilities, procedures, processes, and management resources required to implement the principles and actions necessary to comply with EU MDR 2017/745.

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EU MDR – Article 117

EU MDR – Article 117

EU MDR’s Article 117, is a very short article, but with a great impact on the procedures for marketing medicinal products integrated with medical devices.

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Registrations

Labelling Requirements

Labelling Requirements

Economic OperatorSwissEUUKAR/RPCH REP on the product label. Name Address of the registered place of business. Deadline: MDD: 26/05/2021 MDR: 26/05/2021 (if applicable depending on transition period)OMC Swiss AR Address: OMCS Medical Gmbh C/O Mr...

Authorised Representatives 

Swiss Manufacturer Obligations

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...

Switzerland AR Responsibilities

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,...