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Regulatory Consulting: Support in the MDs and IVDs CE Marking Process

Consulting
Pricing/Discount Options: Call #2 Call #1
Unique Identifier: d4b4424d-f40f-4a41-98cf-11f888e27864

Service Description

With special focus on active devices, IPN supports manufacturers, distributors, and importers of MDs and IVDs, in the CE marking process taking into account the applicable requirements of Regulation (EU) 2017/745 (Medical Device Regulation - MDR) or Regulation (EU) 2017/746 (In Vitro diagnostic Medical Device Regulation – IVDR), as applicable. In this context, IPN supports the implementation and review of the Quality Management System (QMS), together with the elaboration or revision of the Technical Documentation (TD) of the device (under Annex II and Annex III of MDR or IVDR). IPN also support the company, depending on the device class, with the submission of the certification request to a notified body.

Keywords: MDR Medical Devices SaMD quality management system technical documentation IVD IVDR
Offerings: Ethics & Regulatory Affairs Conformity & Compliance (certification, audit, corrective and preventive action, documentation, gap & risk analysis, etc.) Clinical Investigation Support (clinical studies & trials, coordination, design, feasibility, documentation, compliance, operations support) Development of conformity evaluation standards, protocols & tools
TEF-Health Use Case Domain: all
Provider Logo

Provider & Contact

Provider Organisation Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)
Provider Country Portugal
Published Email medicaldevices@ipn.pt

Pricing is available to registered users. SMEs receive significant state-aid reductions (GBER) — or, depending on the call, free services during the funded project. Sign in or register to see the price for your organisation.

Operational Details

Service Inputs 1- Device description and general information. 2- Test reports (according to mandatory applicable standards) 3- raw material technical information (if applicable) 4- Risk report
Service Outputs Technical Documentation
Dependencies & Restrictions MDR; IVDR
Certification Support CE Marking (MDR, IVDR)
  • CE Marking
  • IVDR 2017/746
  • MDR 2017/745

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