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Declaration Of Conformity (DOC)

EU MDR 2017/745 Regulations

New European Medical Device Regulation (MDR) 2017/745, which is a comprehensive set of regulations governing medical devices in the European Union (EU). It was adopted by the European Parliament and Council in April 2017 and came into effect on May 26, 2021, replacing the previous Medical Device Directive (MDD) 93/42/EEC and Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC.

 

EU MDR consultants are professionals who specialize in helping medical device manufacturers such as equipment, single-use devices, medical software, implants, various active and non-active devices, reusable devices, hospitable consumables, etc and other stakeholders comply with the requirements set forth by the EU MDR.

 

These regulations, which came into effect on May 26, 2022, are designed to ensure the general safety and performance of medical devices marketed within the European Union.

 

Key provisions of the MDR 2017/745 include:

 

  1. Classification of Medical Devices
  2. Conformity Assessment
  3. Post-Market Surveillance
  4. Unique Device Identification (UDI)
  5. Clinical Evidence
  6. Notified Bodies
  7. Traceability

 

Compliance with the MDR is mandatory for all medical devices imported or manufactured for sale in the EU, and non-compliance can result in rejection at the port of entry, product recalls, suspension of CE certificate or other regulatory actions.

“Do you have an MDR transition strategy in place if you are planning for the first time? Don’t be concerned; you’re not alone. We are MDR consultants and regulatory experts!”

Roles and Responsibilities of Consultants

The role of 2017/745 EU MDR consultants is to provide guidance and support to medical device manufacturers, importers, and distributors to ensure compliance with the regulation. The MDR 2017/745 consultants can help with various aspects of compliance, including:

 

  • EU MDR Consultants help manufacturers develop a regulatory strategy that aligns with the requirements of the MDR 2017/745. This includes determining the appropriate classification for the device, identifying applicable standards and regulations
  • MDR Consultants assist with the preparation and review of technical documentation required for MDR 2017/745 compliance. This includes all sections detailed in Annex II
  • MDR Consultants help manufacturers establish and maintain a QMS that meets the requirements of the MDR 2017/745. This includes developing and implementing procedures for design control, risk management, and post-market surveillance
  • EU MDR Consultants can assist with the planning and execution of clinical evaluations required for MDR 2017/745 compliance. This includes identifying appropriate clinical data sources, designing and conducting clinical studies, and analyzing and reporting the results as per Article 61
  • MDR Consultants supports manufacturers in establishing and maintaining a post-market surveillance system that complies with the requirements of the MDR 2017/745. This includes monitoring and reporting adverse events, conducting trend analysis, and developing PSUR
  • MDR Consultants assist with the interaction with notified bodies for MDR 2017/745 compliance. This includes preparing and submitting applications for CE marking, responding to notified body requests for information, answering review comments and participating in audits and inspections

 

I3CGloabl locations globally are QMS certified to ISO 13485 and data security certified to ISO 27001, which demonstrates our commitment to overall quality and document security in our customer service operations. Our consultants, Leads and Managers are responsive to answering customer technical emails within 24 hours, as it demonstrates our timely communication.

 

Generally, we at I3CGlobal help manufacturers navigate and document the complex regulatory requirements of any type and class of device and ensure the Notified Body approval on time, thereby without description the products can be sold in the EU territory.

EU MDR Consulting Fee

The cost of EU MDR consulting depends on the type and number of devices, models, and variants under each device scope. For more information, click here >>