Blogs, News, and Resources

Trending Now

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...

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,...



Associate and Intern Role – Regulatory Affairs

We are inviting applications for Associate Role - Regulatory Affairs No. of positions: 05 Experience Level Entry & Mid-Level Mid-Level: 2-5 years of experienceIn this role, you will be expected to have the following attributes:• Work on deadlines• Highly...

read more

February Newsletter

EUROPEAN UNION (EU) MDCG guidance on vigilance terms and concepts of EU MDR | 14 February 2023 The MDCG 2023-3 guidance document clarifies some of the essential terms and concepts in Section 2 of Chapter VII of the Regulation (EU) 2017/745 on medical devices (MDR)....

read more

Technical Documentation Requirements MDD Vs MDR

MDD A MDD Technical documentation must include: A general device description, including any information on any planned variants Design drawings, details on the planned method of manufacture, diagram of components, sub-assemblies, circuits etc Descriptions and...

read more


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.

read more

Subscribe to Monthly Regulatory Newsletter


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,...