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Merc support its customers in defining a regulatory strategy for product approval and in the different design and development phases.

We work together with our customers to find the best regulatory path for a successful access to European and International Markets.

The regulatory services Merc provides are organised in order to cover all the Regulatory activities related to the product life cycle. The regulatory services are addressed to European and no-EU countries like: US (510K and PMA), Canada, China, Japan, Russia, Far East South America, etc

MANUFACTURER’S INCIDENT REPORT MANUFACTURER’S INCIDENT REPORT

From January 2020 the updated version of the Manufacturer’s incident report form V 7.2 will become mandatory, as per indicated in “Additional guidance regarding the vigilance system as outlined in MEDDEV 2.12-1 rev. 8”.

Merc can support you in the implementation of the new regulatory requirements in your vigilance system.    

Classification of medical device according to MDR 2017/745 Classification of medical device according to MDR 2017/745

The Regulation 2017/745 introduces new classification rules and changes some rules of the MDD 93/42/CE. Merc will help you classify your medical devices according to the MDR 2017/745and make an analysis of the impact of Regulation on product certification process.

Technical File Technical File

Technical Files are a Key element in for the success of product approval. Merc will help you identify the most suitable file layout in order to fulfill all possible Regulatory Requirements (MDR 2017/745, US and STED model requirements).

Vigilance system Vigilance system

European Directives and future Regulation 2017/745 on Medical Devices require the implementation of a vigilance system to identify possible incidents and report them to the Competent Authorities.

Merc will support you with the development and implementation of a vigilance system as well as in the reporting activity (when is needed, how to report and at whom).

Post-Market Surveillance Post-Market Surveillance

Merc is able to support you in the post-market surveillance system development and implementation, including MDR 2017/745 requirements.

The Surveillance service of Merc covers also activities outside Europe.

National and International Registrations and Notifications National and International Registrations and Notifications

Even if the product is already CE marked, it could be necessary to notify the product to the national Competent Authority. Some European Countries require having a National Notification before putting the product on the market.

Merc is able to support you in the identification of the necessary information and in the notification process.
If you have any other questions related to international registration (Japan, Taiwan, China, South America, Australia, India, etc.) we are able to support you.

Regulatory Daily Support Regulatory Daily Support

We issue regular updates on the new requirements for medical devices and offer continuous regulatory support to small- and medium-sized companies.

Clinical Study Submission Clinical Study Submission

A key element for a Clinical Study progress is the regulatory path necessary to obtain all the mandatory approvals. 

Merc will support you in these activities, developing the appropriate documentation and answering the questions that the authorities may rise.

Italian medical devices registration database Italian medical devices registration database

Medical Devices, Active Implantable Medical Devices and In Vitro Diagnostic Medical Devices to be placed on the Italian market for the first time must be subjected to a Pre-Market Registration into the database of the Italian MoH.

We can help you access new markets and obtain medical device approval in Italy. We have established relationships with local Institutions, and know how to complete your registration in order to obtain medical device approval as efficiently as possible. We can also support you with the update of the medical devices registration in the database.

Clinical Evaluation Clinical Evaluation

Merc is able to provide you with support in preparing the Clinical Evaluation of the product according to the guidances and the MDR 2017/745.

EU Representative EU Representative

Merc can act as your independent regulatory representative in Italy and Europe.

Person responsible for Regulatory Compliance Person responsible for Regulatory Compliance

Merc is able to offer "the role of a person responsible for regulatory compliance" for Manufacturers and European Authorized Representatives.