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June Newsletter 2023

EUROPEAN UNION Implementation of Regulation (EU) 2023/1194 on transitional provisions for products...

May Newsletter 2023

EUROPEAN UNION (EU) Updated guidance on significant changes under MDR | 12 May 2023 The guidance...

April Newsletter 2023

Germany Database for In vitro diagnostics medical devices notification | 25 April 2023 In Vitro...

March Newsletter 2023

EUROPEAN UNION (EU) Guidance on MDR transitional period extension | 28 March 2023 The amendment of...

February Newsletter

EUROPEAN UNION (EU) MDCG guidance on vigilance terms and concepts of EU MDR | 14 February 2023 The...

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...



Establish a Medical Device Startup Company

Medical device startups play an essential role in revolutionising patient care and improving quality of life. If you share our passion for innovation, starting a medical device company could prove rewarding yet challenging – this article offers comprehensive guidance to help get one started.

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June Newsletter 2023

EUROPEAN UNION Implementation of Regulation (EU) 2023/1194 on transitional provisions for products without an intended medical purpose | 21 June 2023 The deadlines for Annex XVI products mentioned in Implementing Regulation (EU) 2022/2346 has been extended in the...

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Software As a Medical Device and Its Clinical Evaluation

INTRODUCTION: As technology advances across all healthcare fields, Software plays a significant role in all products. It is widely integrated into digital platforms serving both medical and non-medical purposes. Medical device software is one of three types of...

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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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MDCG Guidance for Manufacturers of Class I Medical Devices

MDCG Guidance for Manufacturers of Class I Medical Devices

This document is intended to serve as guidance for Class I medical device manufacturers (excluding custom-made devices) that sell products bearing their name or trademark on the Union market in order to comply with MDR requirements. This guidance should also apply when an importer, distributor, or any other legal entity takes on the obligations owed by manufacturers.

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,...