MERC - International Medical Technology Services

Merc is a consulting company acting in the field of medical devices.
With our extensive experience in the medical device industry, we offer you knowledge and support in all the different aspects of the Market Access of a new product, from regulatory requirements to distribution definition at an International level.

Our core competencies include all activities related to the medical device life cycle from the product development to the market and post-market surveillance as well as medical technology services.

Medical Technology Services

We provide companies with a global regulatory strategy for product and technology development, quality system compliance, clinical trial consulting, i...

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30/10/2020 UDI labelling will be introduced in Singapore for medical devices

Singapore’s Health Sciences Authority (HSA) will introduce a Unique Device Identification (UDI) system for medical devices starting from 2022. Following the US and EU steps, Singapore, among other countries such as Brazil, Saudi Arabia, and China, started implementing a new UDI system. The main rea...

21/09/2020 New UK registration requirements and UKCA mark

From 1 January 2021, there will be new MHRA registration requirements indicating how medical devices will be placed on the UK market. It is safe to say that the requirements are phased in depending on the risk class. Below there’s an indicative time frame for the specific classes: 4 months: Class...

21/09/2020 Vigilance on Medical Devices

The Report on medical devices Vigilance activities was published by the Italian Ministry of Health to share with all those involved in the medical devices sector the data obtained from the analysis of Vigilance activities, in order to ensure the circulation of safe medical devices to be used by pati...