MDR 2017/745

EU Medical Device Regulation is the new regulation that makes its way after negotiations between the European Commission, European Parliament, and the European Council. New medical device regulation replaces the Medical device Directives (93/42/EEC) and the Active Implantable Devices Directive (90/385/EEC).

The background work for the EU MDR by the European Commission dates back to 2012 when a plan to restructure the Regulatory Framework and revise the existing regulations was laid down. The new regulation was first read out in the Parliament in 2014, and the final text was available in June 2016. After the current translation works into the official European Languages, it is expected that the MDR will be available for application by May 2017.

The overall objective of the MDR CE Marking has been to ensure a high level of protection of human health and safety and to provide a framework that is Conducive for the Innovation and competitiveness of the European medical device market.

    • Increased accountability of European Authorized Representatives
    • Stringent Clinical Evaluation
    • More Technical Documentation Requirements
    • EUDAMED Database
    • Implementation of UID
    • New classification method

The definition of Medical Device CE Marking is provided in MDR 2017/745, Article 2. The following devices fall article 2 definition, for example:

    • General use medical devices (Sterile and Non-Sterile)
    • Active Medical Devices
    • Non-Active medical device
    • Implantable Medical Devices
    • Medical equipment and machinery
    • Home Healthcare Devices
    • Software as Medical Devices (SAMD)
    • Active Implantable Medical Devices

Before being sold in the European Economic Area, medical devices must be CE marked. CE Marking verifies that your Medical Device has been evaluated by a

What is the process for obtaining CE certification? What is the CE Marking Approval Process for MDR? What goes into making a Technical File? The flow chart below answers many of the questions.

CE Marking Approval Process

Notified Body and complies with EU safety, health, and environmental regulations. You must create a technical file showing that your Medical Device / Medical Instruments / Medical Disposables / Medical Software / Medical Machinery / Home Health Care Devices meets all of the EU Medical Device Regulation (MDR) standards before applying the CE Marking.

Following CE certification, the manufacturer/importer must establish the CE marking logo on the medical device in accordance with medical device regulation. The CE Marking logo must be visible on both the primary and secondary packaging of the device.

Over the last four years, we have spent a significant amount of time and money building our in-house team MDR consultants‘ expertise to make I3CGLOBAL the best CE Marking consultants. By doing business in the cloud, we can provide multidisciplinary insights into Risk Analysis, Biological Evaluation, Clinical Follow-up, and Clinical Evaluation whilst minimizing travel and lodging costs.

We represent our global and local clients with the same intense emphasis on quality suitable for early CE Certification, thanks to our organization’s common, clear strategy and structure.

Before the final implementation of the EU MDR, all of the necessary and inevitable improvements are unknown. This will prove to be a time-consuming and difficult process for all medical device manufacturers. As a result, it is recommended that you stay informed about upcoming changes and their implications for your system and obtain expert technical advice from Mdr Consultants team of I3CGlobal for implementation and enforcement.

Medical Device Classification

As per MDR Article, 51 Medical Devices are divided into class I, IIa, IIb, and III, taking into account the intended purpose of the devices and their inherent risks. Medical Device Classification is mainly based on the following factors:

  • Does the device have a standalone action?
  • How long is the device in continuous use in the human body?
  • Is it an invasive device or a surgically invasive Medical Device?
  • Is it an implantable or active medical device
  • Does the Medical Device serve the purpose of the use of certain drugs?

The Medical Device is classified into:

  • Class 1
  • Class 1 Sterile
  • Class 1 Measuring
  • Class 1 Reusable
  • Class 11a
  • Class 11b
  • Class 111
Risk Class Risk Description Example
Class III High Drug-eluting cardiac stents, Absorbable Sutures, AIMD
Class IIb Medium-High Ventilators, orthopaedic implants, Radiotherapy equipment
Class IIa Medium-Low Surgical Blades, Suction equipment
Class I sterile Low Sterile dressings, Sterile gloves
Class, I measuring Low Volumetric urine bag
Class I basic Low Non Sterile Gloves

Medical Device Classification – Additional Information’s

Class 1 medical devices, according to the European Medical Device Regulation (MDR), have a low risk of causing damage to the patient and are therefore easier in nature than Class 1s, Class 1m, Class IIa, Class IIb, or Class III medical devices. The majority of Class 1 medical devices can be self-certified under EU MDR. It is not required that a Class 1 medical device be CE marked or that a Notified Body be involved. ISO 13485 introduction and certification are not needed for Class 1 component manufacturers.

QMS  enforcement is recommended as a minimum. In some words, certain controls are adequate to provide fair confirmation of the device’s protection and efficacy. By self-declaration, any Class 1 medical device may affix CE Mark. The manufacturer is responsible for ensuring that his product meets all of the Directive’s Essential Requirements and must fill out the Essential Condition Check-list.

We support class 1 Medical Device manufacturers with the following Services

(a) Guidance & Technical File

(b) Arrange Certificate of Compliance from and European Third Party.

(C) Arrange EU Representative from Europe

(d) Arrange Free Sale Certificate from Europe.

Steps before Class 1 Medical Device Self Declaration

All class 1 medical devices must go through few steps before placing them on the European market. They are the following.

    • Step 1: Research and competitor analysis and make sure the product is a medical device.
    • Step 2: Confirm that the Medical Device falls under self-declaration, i.e., class 1.
    • Step 3: Ensure that the general safety and performance requirements have been met.
    • Step 4: Clinical Evaluation performed and Report is available as per MDR and MEDDEV 2.7/1 Rev. 4
    • Step 5: Availability of Primary & Secondary Labels and packing plans
    • Step 6: EAR Agreement for Non-European manufactures.
    • Step 7: Assure the latest revision of Technical documentation is available with the declaration of Conformity.
Third-Party CE Compliance Certificate for Class I Medical Devices

Non-sterile, non-measuring medical instruments in Class 1 do not need to be certified by a Notified Body and should instead be certified by a third-party approval body. Manufacturers must realize that a third-party certificate is not needed for class 1 devices; instead, a self-attested declaration of compliance will suffice.

Class 1 Sterile Medical Device CE marking, Notified Body involvement is mandatory. Class 1 sterile manufactures should implement ISO 13485, and certification is recommended. GMP controls are necessary.

Class 1 Sterile Medical Device must comply with all the requirements for Class I devices. Establish and maintain the relevant procedures of a Medical Device Quality Management System.

Contact a Notified Body who can audit the Quality Management System and Technical Files.

Criteria for determining devices with measuring function.

The following criteria, if fulfilled together, indicate that a device has a measuring function:

  • The device intended to measure, quantitatively, a physiological or anatomical parameter, or – a quantity or a qualifiable characteristic of energy or of substances delivered to or removed from the human body.
  • The measurement results are displayed in legal units or other acceptable units within the meaning of Directive 80/181/EEC or are compared to at least one point of reference indicated in legal units or other acceptable units in compliance with the pre-mentioned Directive.
  • The intended purpose implies accuracy, claimed explicitly or implicitly.

Measuring activities during the manufacturing process, including those for calibration purposes, are not covered by this recommendation and do not imply a measuring function of the manufactured device.

Examples for Class I devices with a measuring function:

    • Non-active device for measuring body temperature.
    • Pacifier, which includes a non-active temperature display.
    • Device for indicating that body temperature is above or below a specified value.
    • Non-active non-invasive device for measuring blood pressure.
    • Non-active device for measuring intraocular pressure.
    • Device for measuring volume or flow of liquid or gases delivered to or removed from the human body.
    • Device for liquid delivery to the human body (e.g. medicine spoons, cups, droppers, without graduation or scale).
    • Device for displaying trends of physiological parameters (e.g. urine drainage bags without graduation or scale, callipers for obesity).
    • Eye-test chart

Note:- it is assumed that the relevant classification rules permit classification in Class I, provided that relevant criteria are met.

    • Class 1 Device with measuring functions are packed and supplied in a sterile condition require Notified Body Certificate, whereas the non-sterile class 1 measuring device does not!
    • ISO 13485 is Voluntary

EU MDR 2017/745 introduces new requirements for Reusable Surgical Instruments. All reusable surgical instruments fall under class 1r and are subject to conformity assessment by Notified Bodies.

Reusable Surgical Instruments are defined as “instruments intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection, and sterilization have been carried out.

MDR Class Ir CE Marking as per Article 20.1, 20.3, 20.4, and 20.5 and Article 52 (7c) can be achieved in the following methods:

    • Examination and testing of each product or homogenous batch of products (Annex IV)
    • Audit of the production quality assurance system as per Annex VIII, Chapter 1, 2.3(Annex V) and EN ISO 13485:2016 (excluding Design)
    • Audit of final inspection and testing (Annex VI) EN ISO 13485:2016 (excluding Design & Manufacture)
    • Audit of the full quality assurance system (Annex II) EN ISO 13485:2016

In short, Class Ir Reusable manufactures has to.

    • Upgrade existing Technical Files in line with MDR requirements with more details related to reuse, particularly cleaning, disinfection, sterilization, maintenance, functional testing, and the related instructions for use.
    • Clinical Evaluation and Risk Assessment documentation.
    • Issue a Declaration of Conformity.
    • EN ISO 13485:2016 Implementation.

We support class Ir Medical Device manufacturers with the following Services.

  1. Guidance & Technical File
  2. Identify test requirements and review the external reports.
  3. Arrange Notified Body and Coordinate with them till the issue of CE Certificate.
  4. Arrange EU Representative from Europe
  5. Arrange Free Sale Certificate from Europe.

Class IIa Medical Device is critical compared to class 1 devices. Self-declaration is legally not possible. Technical File should be submitted to the Notified Body, and conformity assessment by Notified Body is required before affixing CE Mark.

Possible Class IIa CE Certification options
    • Examination and testing of each product or homogenous batch of products (Annex IV)
    • Audit of the production quality assurance system (Annex V) EN ISO 13485:2012 (excluding Design)
    • Audit of final inspection and testing (Annex VI) EN ISO 13485:2012 (excluding Design & Manufacture)
    • Audit of the full quality assurance system (Annex II) EN ISO 13485:2012

We offer class IIa Medical Device, clients

  1. Guidance & Technical File
  2. Identify test requirements and review the external reports.
  3. Arrange Notified Body and Coordinate with them till the issue of CE Certificate.
  4. Arrange EU Representative from Europe
  5. Arrange Free Sale Certificate from Europe.

As per Medical Device Regulation (MDR), Class IIb Medical Device are critical. Design review and QMS implementation will be verified along with the technical file and Clinical Evaluation (meddev Rev 4) documents. Conformity assessment by a Notified Body is required before affixing CE Mark.

Possible Class 2b Medical Device CE Certification options
  • Type / Batch Examination and testing as per Annex IV
  • Onsite Audit of the production quality assurance system (Annex V) including Design
  • Audit of final inspection and testing (Annex VI) excluding Design & Manufacture
  • Audit of the full quality assurance system (Annex II) EN ISO 13485:2016

We support class IIb Device manufactures the following Services

  1. Guidance & Technical File
  2. Identify Biocompatablity test requirements and review the external Protocols and Reports.
  3. Prepare Clinical Evaluation Reports as per Meddev 2.7/1 Rev 4.
  4. Conduct Risk Analysis and prepare Risk Management Files as per EN ISO 14971.
  5. Arrange Notified Body and Coordinate with them till the issue of CE Certificate.
  6. Arrange EU Representative from Europe
  7. Periodic Safety Update Report.
  8. Arrange Free Sale Certificate from Europe.

CE Marking for Class 3 Medical Devices According to annexes II and III, the marking standards in MDR are far higher. This is where rigorous protocols will be implemented, owing to the fact that these devices pose the biggest danger to patients. According to MDR specifications, the majority of essential medical instruments are classified as Class 3. In comparison to other medical device manufacturers, all Class III medical device manufacturers must undergo rigorous performance and safety checks and clinical evaluation, as per the current MedDev 2.7.1 rev 4 guidelines.

Class III Medical Device manufactures have to submit Technical documentation or file to the Notified Body for approval under Annex II and do not allow the Annex III / Annex VI option.

Definition & Examples for Class III Medical Devices

Class 3/111 follows the same guidelines as 1s, 2a, 2b, but also has to have Notified Body design Examination and Technical Documentation or Technical File review before affixing CE Logo on your medical device. Class III, at times, will be relied on to sustain human lives, so malfunctions are not acceptable in any manner. Some examples would be pacemakers, cerebral simulators, and heart valves, medicated bandages, etc.

Notified Body must carry out audit under Annex II full quality assurance system (EN ISO 13485:2016), plus that the manufacturer must submit the Technical File / Design Dossier to the Notified Body for approval under Annex II, for all type of Class III medical devices including medical devices with ancillary medicine.

(OR)

Type-examination (Annex 3) plus one of the two options given here:

  • Batch Inspection as per Annex IV
  • Audit of the production quality assurance system (Annex V) EN ISO 13485:2016 (with mandatory Design evaluation)

Need help in the Class III approval process?

    • Technical Documentation covering the following,
    • Risk Analysis,
    • Clinical Evaluation,
    • Post Market Surveillance,
    • Post Market Clinical Follow Up,
    • IFU /User Manual review
    • Notified Body Technical Documentation /Technical File clearance.

We support Medical Device manufacturers with the following Services:

  1. Guidance, Preparation, NB Submission, and Answering to Notified Body.
  2. Conduct Biological Evaluation.
  3. Review the external Protocols and Reports.
  4. Conduct Clinical Evaluation and Prepare Clinical Evaluation Reports as per Meddev 2.7/1 Rev 4.
  5. Conduct Risk Analysis and prepare Risk Management Files as per EN ISO 14971.
  6. Arrange Notified Body and Coordinate with them till the issue of CE Certificate.
  7. Arrange EU Representative from Europe.
  8. Arrange Free Sale Certificate from Europe.
  9. Development of Clinical Evaluation Report.
  10. Post Market Surveillance (PMS).
  11. Post Market Clinical Follow Up (PMCF).
  12. Periodic Safety Update Report (PSUR).

MDR Technical Documentation

Technical Documentation, so-called Technical File for Medical Device, is a comprehensive file covering complete information to demonstrate the device’s safety and performance against the manufacturers claimed intended use. The information given in the Technical Files is structured as per MDR and IVDR requirements suitably to address General Safety and Performance Requirements (GSPR).

The notified body will audit technical files annually to assess compliance with general safety and performance requirements. The Technical File should be developed for all types of device risk classes. ( I, Is, Im, Ir, IIa, IIb, III).

The latest version of Technical Files must be retained either in electronic or hardcopy form at manufacturer premises or authorized representative premise for potential request from an EU competent authorities or from Notified Body. During the initial phase of the CE Marking application, complete technical documentation must submit to the notified body. After closing all review comments and updating the technical file, the notified body issues CE Certificate.

All manufacturers need to update their technical documentation as all are aware of the change in regulation from MDD / IVD to MDR / IVDR. We are medical device regulatory consultants who provide MDR / IVDR remediation services. MedDeviceCorp team has gained sufficient knowledge in MDR/IVDR via training, internal debate, conferences, workshops, and live-up-gradation services.

MDR Technical Documentation Requirements

According to the new Medical Device Regulation, annex II identifies forty-seven specific requirements about the primary file technical documentation content and fifteen additional requirements from annex III on Post Market Surveillance.

Article 10 describes the obligation of manufacturers what is needed and why it is needed in the Medical Device Regulation Technical Documentation. Article 15 insists on an experienced regulatory person and his role in updating the Technical Documentation anytime for Notified Body assessment. While preparing a tech file, you should have sound knowledge technically to present information in the correct way; some of the core areas are the following.

    • Review existing documentation in support of meeting the applicable MDR Essential Requirements.
    • Study the device, Identify and evaluate gaps or deficiencies in your new EU MDR.
    • Determine applicable testing requirements and standards for your device after a Risk Analysis.
    • Organize Clinical Evidence in the form of a Clinical Evaluation Report (CER).
    • Preparation of Post Market Surveillance Report (PMS) and derive the conclusion of CER.
    • Preparation of Post Market Clinical Follow-Up Report (PMCF) and derive the conclusion of CER.
    • Review your specimen labelling and Instructions for Use (IFU)and User Manual.
    • Compile Pre-Clinical Verification and Validation documentation.

The MDD’s Design Dossier concept has been removed from the new EU MDR. 

We can deliver structured solutions for developing high-quality Technical Documentation for any risk class, starting from drafting the File, reviewing and modifying the contents, supporting filling the Gaps, submitting to Notified Body of your choice, and coordinating with Notified bodies till documentation is approved.

If you are finding ways to update a legacy medical device technical file to meet new medical device regulation, we at MedDeviceCorp help with Medical Device Technical File remediation service. After a thorough understanding of your subject device, we start our guidance and preparation to identify disparities between your medical device and present technical file/requirements. Unlike others, we do not allow the client team to work on the technical file till the successful completion of the CE Certification project.

You may be confused; even though you appoint a consultant, who is doing what? How to do it? What should we do? Please read the below table for your information.

SL NO DESCRIPTION OF ACTIVITY CLIENT CONSULTANT
01 Description of the Device As to be provided as per Consultant instruction
02 Intended use of the device To be provided as per Consultant instruction
03 Device models & Specification To be provided as per Consultant instruction
04 Mechanism of action To be provided as per Consultant instruction
05 Classification and justification of Medical Device Consultant will provide
06 List of Applicable Directives Consultant will provide
07 List of Applicable MDD Guidelines followed Consultant will provide
08 List of Applicable Harmonized Standards The client has to provide after taking advice from a consultant.
09 List of Applicable Non-Harmonized Standards The client has to provide after taking advice from a consultant.
10 Declaration of Conformity Consultant will Draft
11 Use of Animal Origin products Consultant will provide
12 Use of Blood or Blood Components Consultant will provide
13 Integration of a Medicinal Product into the Device Consultant will provide
14 Product Design documents The client has to provide as per ISO 13485 The consultant will review and guide wherever necessary
15 Connection to other Devices The client has to provide
16 Phthalates Free Declaration Consultant will provide
17 EC Representative The client has to organize The consultant will draft if required.
18 Essential Requirement Checklist Consultant will provide
19 Risk Analysis As per ISO 13485 and EN ISO, 14971:2007 Client has to provide The consultant will review, modify according to NB
requirements
20 Clinical Evaluation Consultant will provide
21 Description of Manufacturing The client has to provide
22 Critical process & MSDS The client has to provide The consultant will guide and review the documents
23 Description About critical suppliers and their quality certificates The client has to provide
24 Environmental controls To be provided as per Consultant instruction The consultant will guide and review the documents
25 Pre-clinical testing To be provided as per Consultant instruction The consultant will guide and review the documents
26 In-House test reports To be provided as per Consultant instruction
27 Bill of materials The client has to provide
28 Device shelf life The client has to conduct the study report Consultants will provide guidance
29 Biocompatibility The client has to organize the report Standard Identification by consultant
30 Electrical safety The client has to organize the report Standard Identification by consultant
31 Product Specific Standards The client has to provide
32 Usability To be provided as per Consultant instruction The consultant will guide and review the documents
33 Software validation To be provided as per Consultant instruction
34 Sterilization To be provided as per Consultant instruction The consultant will guide and review the documents
      35 Quality Controls The client has to provide documents as per consultant instructions.
36 Device Labelling The client has to provide documents as per consultant instructions.
37 Device Packing The client has to provide documents as per consultant instructions.
38 Storage and Transportation The client has to provide documents as per consultant instructions.
39 Packaging validation The client has to provide documents as per consultant instructions The consultant will guide and review the documents
40 The lifetime of the device The client has to provide documents as per consultant instructions The consultant will guide and review the documents
41 Post Manufacturing Activities The consultant will prepare related procedures &relevant templets as per ISO 13485

Preparing MDR 2017/745 Technical File is a tedious process. Proper understanding, Technical Knowledge & team efforts, along with an experienced team of consultants, are highly essential for the timely completion of MDR Technical Documentation / Technical File. The below table explains the technical file content only for study and information only.

1.0 TABLE OF CONTENTS
2.0 NATURE OF AMENDMENT
2.1 Issue Register
2.2 Revision Register
3.0 WARNING
4.0 TECHNICAL FILE
5.0 PURPOSE
6.0 SCOPE
7.0 COMPANY PROFILE
8.0 DEFINITION OF TERMS
8.1 Technical file
8.2 Design Dossier
9.0 MEDICAL DEVICE INFORMATION
9.1 Device models and Variants
9.2 Description of the Device
9.3 Intended use of the Device
9.4 Mechanism of Action
10.0 DESIGN DOSSIER
10.1 Device Drawings
10.2 Device Specifications
10.3 Design Approvals
10.4 Design Transfer
10.5 Bill of material
11.0 MDD COMPLIANCE
11.1 Classification and justification
11.2 List of Applicable Directives
11.3 List of Applicable MDD Guidelines followed
11.4 List of Applicable Harmonized Standards
11.5 List of Applicable Non-Harmonized Standards
11.6 Use of Medical Substance
11.7 Use of Animal Origin products
11.8 Use of Blood or Blood Components
11.9 Integration of a Medicinal Product into the Device
11.10 Connection to other Devices
11.11 Declaration of Conformity
11.12 EC Representative
11.13 Essential Requirement Check List
11.14 Risk Analysis
11.15 Post Market Surveillance (PMS)
11.16 Post Market Clinical Follow-up (PMCF)
11.17 Clinical Evaluation
12.0 MANUFACTURING PROCESS
12.1 Description of Manufacturing
12.2 Description About critical process
12.3 Environmental controls
12.4 Critical suppliers
12.5 Critical Process(validations)
12.6 In-house Testing
12.7 Pre- Clinical Testing
12.8 Biocompatibility
12.9 Electrical Safety
12.10 Usability
12.11 Sterilization
12.12 Software Validation
13.0 PRODUCT PACKING AND TRANSPORTATION
13.1 Device Labeling
13.2 Device Packing
13.3 Storage and Transportation
13.4 Packaging Validation
13.5 Transportation Validation
13.6 Device shelf-life / Life Time

Medical Device Risk Management

EN ISO 14971:2012 is the latest international standard for the Medical Device Risk Management Process for the Medical Devices( As per Harmonized Standards). The Risk Management Process contains 3 important parts:

  • Risk Analysis
  • Risk Evaluation
  • Risk Control

The Risk Analysis is the starting phase of the risk management process for a medical device. A medical device risk management plan is determined and implemented. The three important stages of the Risk Analysis Process are below.

  • Identification of the intended use and characteristics related to the safety of the medical device.
  • Identification of known or foreseeable hazards
  • Estimation of the risk for each hazardous situation

Risk management Procedure and Report

Thus risk analysis is the systematic use of the available information to estimate the risk in the identified hazards. The risk analysis activities and the results are recorded in a risk management file. Some of the Risk Analysis techniques explained in the standard are:

  • Preliminary Hazard Analysis (PHA)
  • Fault Tree Analysis (FTA)
  • Failure Mode and Effects Analysis (FMEA)
  • Failure Mode, Effects and Criticality Analysis (FMECA)
  • Hazard and Operability Study (HAZOP)
  • Hazard Analysis and Critical Control Point (HACCP)

Depending on the intended use, characteristics, present stage of development of the medical device, one or more of the above techniques can be used for the risk analysis.

Medical Device Risk Management plan

Risk management activities must be planned for every project before the initialization of risk analysis activities.

  • The planning of risk activities shall be coherent with the risk class of the device and Intended use.
  • Putting together your risk management team.
  • Important, list the deliverables and reviews of each phase of the project
  • Suggestions for overall improvement as per Notified Body requirements.

Role of Consultants in Risk Management File

  • Review the hazards and control measures taken
  • Development of annexures as per standard
  • Guidance and suggestions for closing the identified GAPS.
  • Suggestions for overall improvement as per Notified Body requirements.

Fees

(Consulting, Technical File Preparation, Notified Body costing included)

On this page, we detailed the pricing for each major activity involved in medical device CE Certification. We are sure, below information will be very helpful for those planning for MDR CE Marking for the first time. Price variation from the below table happens in the case of multiple models and variants.

You can request a turnkey service quote, including Guidance, Technical Documentation, Biocompatibility or Electrical Safety, European Authorized Representative and Notified Body Fees.

A. MDR Guidance and Documentation Fees

Activity

Class of  Medical Device
1 1s/m 11a 11b 111
(a) MDR Technical File & Guidance $ 2500 $ 3000 $ 3000 $ 3500 $ 4500
(b) Animal Origin Or Radiation Emitting

(Additional Fees to “a”)

 – – – $ 1500 $ 2000
(c) Ancillary Medicinal Substances

(Additional Fees to “a”)

 – – – – $ 2000
(d) Software-driven / Standalone Devices

(Additional Fees to “a”)

 $ 1000 $ 1500 $ 1500 $ 1500 $ 1500
(e) Risk Analysis Support with Usability Files

(Additional Fees to “a”)

 – $ 500 $ 600 $ 850 $ 1000
(f) CLinical Evaluation

(Additional Fees to “a & e”)

 $ 2999 $ 3999 $ 3999 $ 4999 $ 7999
(g) PMS + PMCF + PSUR

(Additional Fees to “a, e & f”)

 $ 1500 $ 1500 $ 1500 $ 2000 $ 3000
(h) Complete Notified Body Coordination till Technical File Approval

(Additional Fees to “a, e, f & g”)

 NA $ 2500 $ 2500 $ 3000 $ 5000

B. IVDR Guidance and Documentation Fees

Activity

  IVD Type / List

Self

B (LR)

B (HR)

A

Guidance on IVD Requirements  related to Device for CE Marking

$ 1300

$ 1400

$ 1500

$ 1600

Preparing Technical File

$ 3800

$ 4300

$ 6500

$ 7000

Support in closing NB review comments

NA

$ 3000

$ 4200

$ 5400

Label Review

$ 500

$ 600

$ 700

$ 800

Important

  • OBL / PLM will be charged 30 % less
  • Payment Terms: Initial Advance 40%, before TF submission 20%, answering initial NB comments 20% and balance after approval.
  • Method of communication: Telephone / Skype / Email.
  • Language for communication – English.
  • Complete Documentation in external Cloud (Dropbox).
  • Minimum Timeline: 45-75 Days.
  • Taxes applicable as per Government rules.
  • Consultant Onsite visit arranged from Bremen Germany, Bangalore India and Chicago USA.
  • Consultant Onsite visit will be invoiced on actuals.
  • Don’t forget to get an NB quote from us for price comparison!!!

C. Notified Body IVDR CE Certification Fees (Reference Only)

Class of Device First Year Fee
EURO INR
Class 1 CE Certification Self Self
Class 1s & Class In CE Certification 10000 800000
Class 11a CE Certification 12000 1000000
Class 11b CE Certification 14000 1200000
IVD ( List B / A) & MDD Class 111 CE Certification 18000 1500000

Important

  • CE Certificate validity is five years
  • Auditor travelling and Lodging additional
  • The annual Surveillance Fee will be 35% of the initial year fee
  • The client should be invoiced separately for unannounced audits by Notified Bodies.
  • Class 1 CE Compliance Certificate can be arranged from Germany Office

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