case study

Clearing a Hurdle for CE Mark: The Clinical Evaluation

Devicor, the leading breast biopsy device manufacturer, engaged RCA to build a clinical evaluation process.

About RCA
Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the pharmaceutical, biologic, sterile compounding, biotechnology, and medical device industries for resolution of compliance and regulatory challenges.

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Clearing a Hurdle for CE Mark: The Clinical Evaluation

Background

Devicor, the leading breast biopsy device manufacturer, wanted an updated CE mark strategy to expand distribution with new products and provide continuity with legacy products obtained through a divestiture. The Medical Device Directive requires a clinical evaluation to verify medical device clinical safety and performance.

RCA’s expertise helped complete the submission, leading to the CE Mark approvals and enabling continuity of existing products and expanded distribution of new product.

Solution

Devicor engaged Regulatory Compliance Associates® Inc. to build a clinical evaluation process. RCA identified clinical data by conducting literature searches based on key words and phrases, filtered through studies and data for relevant information and developed abstracts for incorporation with Devicor’s final submission.

Results

Besides crafting the plan, RCA was instrumental in data collection and analysis of clinical data, reviewing thousands of papers. This expertise helped Devicor complete the submission, leading to the CE Mark registration and enabling continuity of existing products and expanded distribution of new product. Based on this successful experience, Devicor will gladly look to RCA for future needs in clinical evaluations.

About RCA

Regulatory Compliance Associates® Inc. can assist clients that need to comply with the EU MDR requirements with the following services:

1. Preform a Comprehensive Review of Entire Product Portfolio and Current Certificate Expiry Dates

  • Review and Assess the Client’s entire Product Portfolio including its:
    • Legacy Products [CE marked devices under the Medical Device Directives (MDD) 93/42/EEC or the Active Implantable Medical Device Directive (AIMD) 90/385/EEC];
    • Modified Legacy Products; and/or
    • New Products currently in the Design/Development Phase.
  • Confirm whether any Legacy Products and/or Modified Legacy Products have been affected by the new MDR Definitions and/or Reclassification of certain types of products into higher risk classes of devices;
  • Reassess current classification of devices based on MDR Classification Rules;
  • Prepare Product Rationalization Strategy Reports for Legacy Products, Modified Legacy Products, and New Products (as appropriate and applicable). which may assist the Client in making internal decisions about whether to maintain and/or bring such products in compliance with the MDR;

2. Staff Augmentation and Support

  • Readiness Audits / Pre-Certification Audits and/or Assessments

3. Perform a Gap Assessment of the current Quality Management System (QMS) and its Current Processes and Procedures for MDR Compliance.

  • Review and Assess the Quality Management System (QMS) requirements including all current policies, processes, and procedures against ISO 13485:2016 requirements
  • Technical Documentation requirements
    • Labeling requirements (including required languages in each Member States)
    • Unique Device Identification (UDI) System
    • Data entered into the EU MDR EUDAMED Database per Article 33
    • Risk Management System (RMS) 
    • Risk Management Plan and Report dor each device
    • Clinical Data Requirements
    • Data Integrity Best Practices
    • Safety and Performance Requirements
    • Post-Market Surveillance System (PMS)
    • Vigilance Activities
    • Market Surveillance Activities
    • Requirements regarding Design and Manufacture of Devices per MDR requirements

4. Remediation and Implementation of EU MDR Compliance Plan

  • Supply Chain Requirements
  • Development and Implementation of EU MDR Compliance Plan for systems and devices
  • Remediation of EU MDR Compliance Gaps noted during Assessment
  • Development and Implementation of EUDAMED Database compliance plan for all of the following six pillars of the EUDAMED
    • Actor Registration
    • Unique Device Identification
    • Certificate
    • Clinical Investigation
    • Vigilance

Background

Devicor, the leading breast biopsy device manufacturer, wanted an updated CE mark strategy to expand distribution with new products and provide continuity with legacy products obtained through a divestiture. The Medical Device Directive requires a clinical evaluation to verify medical device clinical safety and performance.

RCA’s expertise helped complete the submission, leading to the CE Mark approvals and enabling continuity of existing products and expanded distribution of new product.

Solution

Devicor engaged Regulatory Compliance Associates® Inc. to build a clinical evaluation process. RCA identified clinical data by conducting literature searches based on key words and phrases, filtered through studies and data for relevant information and developed abstracts for incorporation with Devicor’s final submission.

Results

Besides crafting the plan, RCA was instrumental in data collection and analysis of clinical data, reviewing thousands of papers. This expertise helped Devicor complete the submission, leading to the CE Mark registration and enabling continuity of existing products and expanded distribution of new product. Based on this successful experience, Devicor will gladly look to RCA for future needs in clinical evaluations.

About RCA

Regulatory Compliance Associates® Inc. can assist clients that need to comply with the EU MDR requirements with the following services:

1. Preform a Comprehensive Review of Entire Product Portfolio and Current Certificate Expiry Dates

  • Review and Assess the Client’s entire Product Portfolio including its:
    • Legacy Products [CE marked devices under the Medical Device Directives (MDD) 93/42/EEC or the Active Implantable Medical Device Directive (AIMD) 90/385/EEC];
    • Modified Legacy Products; and/or
    • New Products currently in the Design/Development Phase.
  • Confirm whether any Legacy Products and/or Modified Legacy Products have been affected by the new MDR Definitions and/or Reclassification of certain types of products into higher risk classes of devices;
  • Reassess current classification of devices based on MDR Classification Rules;
  • Prepare Product Rationalization Strategy Reports for Legacy Products, Modified Legacy Products, and New Products (as appropriate and applicable). which may assist the Client in making internal decisions about whether to maintain and/or bring such products in compliance with the MDR;

2. Staff Augmentation and Support

  • Readiness Audits / Pre-Certification Audits and/or Assessments

3. Perform a Gap Assessment of the current Quality Management System (QMS) and its Current Processes and Procedures for MDR Compliance.

  • Review and Assess the Quality Management System (QMS) requirements including all current policies, processes, and procedures against ISO 13485:2016 requirements
  • Technical Documentation requirements
    • Labeling requirements (including required languages in each Member States)
    • Unique Device Identification (UDI) System
    • Data entered into the EU MDR EUDAMED Database per Article 33
    • Risk Management System (RMS) 
    • Risk Management Plan and Report dor each device
    • Clinical Data Requirements
    • Data Integrity Best Practices
    • Safety and Performance Requirements
    • Post-Market Surveillance System (PMS)
    • Vigilance Activities
    • Market Surveillance Activities
    • Requirements regarding Design and Manufacture of Devices per MDR requirements

4. Remediation and Implementation of EU MDR Compliance Plan

  • Supply Chain Requirements
  • Development and Implementation of EU MDR Compliance Plan for systems and devices
  • Remediation of EU MDR Compliance Gaps noted during Assessment
  • Development and Implementation of EUDAMED Database compliance plan for all of the following six pillars of the EUDAMED
    • Actor Registration
    • Unique Device Identification
    • Certificate
    • Clinical Investigation
    • Vigilance

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