CE Marking

CE Marking and CE CertificationWe have Experienced and Enthusiastic Professionals that support your organization to get CE Certification as per EU MDR 2017/745 and 2017/746 for your Devices in a very efficient and reasonably shortest Possible Time and in a Cost-effective Manner.

Transition to EU MDR

We have experienced professionals to perform a systematic, independent gap analysis of CE technical documentation, procedures, and processes to help manufacturers understand what steps should be taken to meet requirements of the Medical Device Regulations. Our in-depth MDR gap analysis is done by most senior consultants and includes below given services:

EU MDD to MDR 2017/745 gap analysis

The review/gap analysis will include the assessment of the following:

  • Legacy Device Report Review
  • CE Marking Technical File or Design Dossier
  • Current device class and product families
  • Risk management file review
  • Clinical Evaluation Report(s)
  • Labeling
  • Post-market surveillance (process, plan, effectiveness, PMCF, and results)
  • Periodic Safety Update Report (PSUR)
  • Economic Operators Agreements Review, including your European Authorized Representative (EC REP) agreement
  • Supply and distribution chain management procedures
  • Relations with your current Notified Body
  • Product life cycle plan

We will deliver a comprehensive report detailing deficiencies, with recommendations on how to fix them and the order in which you should address them.


EU MDR Consulting & Compliance

This will include the following:

  • Scrutiny of clinical data and Clinical Evaluation Report (CER)
  • Recurring updates.
  • Increased post-market surveillance requirements
  • Performing more Post-Market Clinical Follow-up (PMCF) studies.
  • Preparation and Submission of Periodic Safety Update Report (PSUR)

Based on the above, our professionals will be able to support as per below:

  • 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;
  • Staff Augmentation and Support
    • Readiness Audits / Pre-Certification Audits and/or Assessments
  • Perform a Gap Assessment of the current Quality Management System (QMS) and its Current Processes and Procedures for EU MDR Compliance.
  • Review and Asses the Quality Management System (QMS) requirements including all current policies, processes, and procedures against ISO 13485:2016 / EN ISO 13485:2016 requirements
  • Technical Documentation requirements
    • Labelling 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 for each device
    • Clinical Data Requirements
    • Data Integrity Best Practices
    • Safety and Performance Requirements
    • Post-Market Surveillance System (PMS)
    • Periodic Safety Update Reports (PSUR)
    • Vigilance Activities
    • Market Surveillance Activities
    • Requirements regarding Design and Manufacture of Devices as per EU MDR requirements
  • Our Experienced Team of Professionals will provide: Remediation and Implementation of EU MDR Compliance Plan for 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 as relevant to your devices, Including;
    • Actor Registration
    • Unique Device Identification
    • Certificate
    • Clinical Investigation
    • Vigilance


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