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Support in Clinical Investigation /Clinical Performance Study Activities

Physical Consulting
Pricing/Discount Options: Call #2 Call #1
Unique Identifier: 68a6f490-881b-4c86-99d7-a81a065b2a99

Service Description

Annex XV of the MDR outlines the requirements for the documentation regarding the application for Clinical Investigations to be conducted within the European Union. Similarly, Annexes XIII and XIV of the IVDR outlines the requirements for the documentation regarding applications for clinical performance studies and other performance studies . IPN is able to provide support in a two-step approach, • Study Documents & Submission Process, supporting the preparation of the mandatory documents and the submission of study to the Regulatory Authorities (ethics committees and competent authorities). In this context, IPN services include: -> Clinical Investigation Plans (CIPs) / Clinical Performance Study Plan (CPSP) -> Investigator’s Brochure (IB) -> Case Report Form (CRF) -> Informed Consent Form (ICF) -> Clinical Investigation Report (CIR) / Clinical Performance Study Report (CPSR) and Supporting Documentation -> Additional specific forms for local ethics committees and Competent Authorities in different countries. • Study Monitoring & Data Management, supporting the Site Initiation activities, recruitment process, monitoring, data collection/analysis and CIR/CPSR according to ISO 14155:2020/ PSR according to ISO 20916:2019 - Good Clinical Practices/ Good Study Practices. If needed, Study Coordination support may also be made available.

Keywords: Clinical investigation Clinical Investigation ISO 14155:2020 Performance Studies ISO 20916:2019 Pilot Studies
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
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Provider & Contact

Provider Country Portugal
Published Email medicaldevices@ipn.pt

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Operational Details

Dependencies & Restrictions MDR; IVDR
Certification Support CE Marking (MDR, IVDR)
  • CE Marking
Service Standards
  • Good Clinical Practices
  • ISO 14155
  • ISO 20916:2019