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November Newsletter

EUROPEAN UNION (EU) EU guidance on reference laboratories for IVD medical devices | 30 November...

October Newsletter 2022

EUROPEAN UNION (EU) Guidance on EU Authorized Representatives | 31 October 2022 Medical Device...

September Newsletter 2022

EUROPEAN UNION (EU) Notified Bodies Position paper on application of hybrid audits for QMS...

August Newsletter 2022

EUROPEAN UNION (EU) MDCG guidance on Notified body capacity and availability of medical devices...

July Newsletter 2022

EUROPEAN UNION (EU) Harmonised administrative practices and alternative technical solutions| 13...

June Newsletter

  EUROPEAN UNION (EU) Guidance document on the implementation of EU product rules 2022 | 29...

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...

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November Newsletter

EUROPEAN UNION (EU) EU guidance on reference laboratories for IVD medical devices | 30 November 2022 EU Commission has published new guidance for candidate reference laboratories in the In vitro diagnostic medical devices field. The document guides laboratories...

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Vigilance in EU MDR

MDR Vigilance is a strategy for gathering information on post-market adverse medical device incidents. Vigilance System strives to lessen the likelihood of incidents while also increasing patients’, healthcare provider, and other user protection. Chapter VII Section 2 of the EUMDR contains the vigilance requirements (Articles 87 to 92).

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Regulations

Article 61 Clinical Evaluation in the EU MDR

Article 61 Clinical Evaluation in the EU MDR

Manufacturers must plan, carry out, and document a Clinical Evaluation in order to comply with the general safety and performance standards outlined in Annex I, as per Article 61. Clinical evaluation is a series of ongoing activities that use scientifically reliable techniques for the evaluation and analysis of clinical data in order to confirm the safety, clinical performance, and/or effectiveness of the medical device when used in accordance with the manufacturer’s instructions.

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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,...