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MDR TECHNICAL FILE GAP ASSESSMENT

We identify the GAPs and Guide appropriate measures

What is DOC?

Check new EU MDR /IVDR Declaration of Conformity Contents

CE Marking Consultants for Medical Device

We are the CE Marking Consultants for Medical Device. Our headquarters is located in Bangalore, India, and has offices in Germany and the United States. We started serving medical device manufacturers from 1999.

 

Our beloved existing customers consider our team members as their own team for medical device regulatory compliance throughout every year.

CE Marking Consultants

The “Perga” has rated us as the best and most rooted CE Marking Consultants in Asia Pacific & Middle East. It is the need of the time to crack obstacles in MDR & IVDR CE Marking, for either old certificate holders or new applicants.

Scope of CE Marking Consultants

General

  1. Discusses with the clients and identifies the Device Scope for CE Marking along with Models, Variants, and Brands.
  2. Discusses and makes aware of EN ISO 13485:2016 Implementation to clients’ team members.
  3. Arranges Organization Structure along with Duties and Responsibilities.
  4. Helps in identifying the Notified Body and submitting the MDR/IVDR Application.

Technical

  1. Identifies product-specific standards, harmonized and general standards applicable to the device with the support of the manufacturer.
  2. Gathers information about materials, components, brought-out items, outsourced items, packing requirement specification along with BOM from Design & Development.
  3. Gathers details about manufacturing process flow, environmental conditions.
  4. Gathers details about device packing, labelling & transportation with the support of the manufacturer.
  5. Defines device description, intended, the indication of use, mechanism of action with the support of the manufacturer.
  6. Supports in safety and performances requirement analysis and testing with the support of the manufacturer.
  7. Performs EN ISO 13485:2016 Internal GAP Assessment/IQA.
  8. Performs consolidation of technical documentation and internal review and correction.
  9. Conducts onsite QMS & Product Audit followed by the closing of all the findings with the support of the manufacturer.

Biological Evaluation

  1. Identifies sources (Internal/External) for the Evaluation of Safety, Biocompatibility Testing, Physical characterization tests, Chemical characterization tests, Stability studies, Validations, Verifications, etc. with the support of the manufacturer
  2. Supports in biological evaluation documentation and testing

Clinical Evaluation

  1. Identifies the equivalent/similar device with same risk biological clinical and technical equivalency with the support of the manufacturer
  2. Conducts detailed assessment about a similar generation(s) of the device available on the European Union or on international markets as given by the manufacturer
  3. Identifies patient population, clinical conditions, contraindications, warnings with the support of the manufacturer
  4. Conducts Clinical Evaluation along with Post Market Surveillance and Periodic Safety Update Report

Risk Analysis

  1. Performs Risk Identification and Benefit-Risk Analysis with the support of the manufacturer
  2. Sets up Risk Management documents such as Risk Management Plan (RMP), Hazard Traceability Matrix (HTM), Risk Management File (RMF), etc. with the support of the manufacturer
  3. Identifies and resolves risk analysis gaps

Post Market

  1. Supports manufacturer in setting up the PMS plan and PMS report/PSUR
  2. Supports manufacturer in carrying out the Post Market Clinical Follow-up (PMCF), sets PMCF plan and associated reports

Declaration of Conformity

  1. Identifies the conformity assessment route and draws a Declaration of Conformity.
  2. Confirms with the manufacturer regarding the details to be added in the DoC such as UDI-DI number, harmonized and non-harmonized standards, common specifications etc.

Notified Body

  1. Work as intermediate between the NB and the manufacturer – technical documentation submission and audit support
  2. Corrects NB review comments, modify/reply to NB with correction and supporting evidences

MDR CE Consultants

Our MDR CE Marking consultants help the medical device manufacturers in commercializing their products in the EU market. As it is the transition time from MDD to MDR, we can help you in identifying what is missing from your technical file and what needs to be added.

 

By now, you might have come to know what changes have been implemented in the MDR compared to the MDD and if not, don’t worry! We, the MDR CE marking consultants can guide you in the right direction to place your medical device in the EU market.

Here are a few points you should take care of while transitioning to MDR and where we – the MDR CE consultants can be of your support:

  • Compliance to General Safety and Performance Requirements
  • Implementation of Unique Device Identifier (UDI) to keep a track of your devices
  • Strong and in-depth clinical data to prove safety and performance claims
  • Stricter equivalency measures
  • New classification rules and addition of re-usable surgical devices requiring NB oversight
  • Reporting of incidents in the EU portal – EUDAMED

IVDR CE Consultants

With the release of IVDR, it has come to everyone’s notice that placing IVD devices in the EU market has become dreadful. As this is the transition time from IVDD to IVDR, we can help you in identifying what is missing from your technical file and what needs to be added.

 

Here are the key changes that you should know before placing your IVD device in the EU market and here are the areas where we, the IVDR consultants, can be of your support:

  • Risk classes – moved from the list-based approach to a risk-based approach. Four risk categories A, B, C & D.
  • Conformity assessment routes were amended – to reflect new classification rules.
  • Performance Evaluation – required throughout the lifetime of the device, must be performed as per Performance Evaluation Plan.
  • Requires providing clinical evidence reports on scientific validity, analytical performance, and clinical performance.
  • Post Market activities – Post-market Performance Report (PMPF) is a new requirement, PMS plan, PMS report, and Incident report and trending.
  • For scrutiny and traceability demands, Summary of Safety and Performance for classes C& D and the need for a Unique Device Identifier (UDI).