CE Marking Consultants

CE Marking Consultants provide manufacturers with the expert advice, documentation support, and guidance needed to navigate the medical device and in-vitro diagnostic device CE Marking process successfully. CE Consultants also ensure that their devices meet all requirements for market access in the European Economic Area.

We are medical device CE marking consultants with operations in India, Germany, the United Kingdom, and the United States. Since 1999, we have been dedicated to providing top-notch services to medical device brand labelers, private labelers, manufacturers and specification developers. Over the years, our commitment to excellence has earned us the trust and loyalty of our clients. They don’t just see us as external consultants; they view our team members as integral parts of their own teams, helping them navigate the complexities of medical device regulatory compliance throughout the year.

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CE Marking Consultants Scope of work

#	Requirement	Activity
1	Scope of CE Marking	Discuss with the clients and identifies the Device Scope for CE Marking along with Models, Variants, and Brands. Discusses and makes aware of EN ISO 13485:2016 Implementation to clients’ team members. Arranges Organization Structure along with duties and responsibilities. Support in identifying the Notified Body and submitting the MDR / IVDR Application.
2	Technical	Identifies product-specific standards, harmonized and general standards applicable to the device with the support of the manufacturer. Gathers information about materials, components, brought-out items, outsourced items, and packing requirement specifications along with BOM from Design & Development. Gathers details about manufacturing process flow and environmental conditions. Gathers details about device packing, labelling & transportation with the support of the manufacturer. Defines device description, intended, the indication of use, mechanism of action with the support of the manufacturer. Supports safety and performances requirement analysis and testing with the support of the manufacturer. Performs EN ISO 13485:2016 Internal GAP Assessment/IQA. Performs consolidation of technical file and documentation and internal review and correction. Conducts onsite Quality Management System & Product Audit followed by the closing of all the findings with the support of the manufacturer.
3	Biological Evaluation	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. Supports in biological evaluation testing and documentation.
4	Clinical Evaluation	Identifies the equivalent/similar device with the same risk biological clinical and technical equivalency with the support of the manufacturer. Conducts detailed assessment about a similar generation(s) of the device available in the European Union or international markets as given by the manufacturer. Identifies patient population, clinical conditions, contraindications, and warnings with the support of the manufacturer. Conducts Clinical Evaluation along with Post Market Surveillance and Periodic Safety Update Report.
5	Benefit-Risk Analysis	Performs Risk Identification and Benefit-Risk Analysis with the support of the manufacturer. Set 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. Identifies and resolves risk analysis gaps.
6	Usability Engineering	Performs Usability Engineering Documentation.
7	IVDR Performance Evaluation	Make a performance evaluation plan based on the clinical evidence provided by the manufacturer such as IFU or User guide, RMF, or previous PER Develop a Literature search plan and add information on literature search strategies Develop an Appraisal plan and add information and necessary criteria’s for appraisal of all the pertinent data Identifies clinical evidence that can be retrieved from the manufacturer Develop relevant Literature search and review report Perform a systematic and comprehensive literature search from scientific databases based on research questions Develop appraisal of clinical evidence plan
8	MDR /IVDR General Safety and Performance Report	Chapter I – general requirements, chapter II – Requirements regarding performance, design and manufacture and Chapter III – requirements regarding Information supplied with the device
9	Post Market Clinical Follow-up	Supports manufacturer in setting up the PMS plan and PMS report/PSUR. Supports manufacturer in carrying out the Post Market Clinical Follow-up (PMCF), sets PMCF plan and associated reports. Supports in selecting the sources from PMS Plan
10	Declaration of Conformity	Identifies the conformity assessment route and draws a Declaration of Conformity. Confirm 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.
11	European Authorized Representative	Draft the agreement and mandate for mutual signing Basic UDI SRN activation *We are European Authorized Representatives and CE Marking Consultants
12	Notified Body	Work as an intermediate between the NB and the manufacturer – technical documentation submission and audit support. Correct NB review comments and modify/reply to NB with corrections and supporting evidence.
13	EUDAMED + UDI	Preparing and structuring the necessary product data for UDI submission Assist in updating product labels with the correct UDI information and ensure that the required data is submitted to the European UDI database (EUDAMED) Develop a tailored strategy for implementing UDI, considering the manufacturer’s specific products and sales units and packaging

EU 2017/745 - MDR CE Marking Consultants

Our EU MDR 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 identify 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! The 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 marking consultants can be of your support:

Compliance to General Safety and Performance Requirements
CE Marking consultants and writers develop technical documentation and maintain and update throughout the review period
Implementation of Unique Device Identifier (UDI) to keep a track of your devices
Collect strong and in-depth clinical data to prove clinical safety 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

EU 2017/746 - IVDR CE Marking Consultants

CE Marking consultants assist in correctly classifying IVD devices according to the new IVDR rules, which have become more stringent compared to the previous In Vitro Diagnostic Directive (IVDD). With the introduction of IVDR, it has become clear that bringing IVD devices to the EU market has become a nightmare.

Based on the product classification, CE Marking consultants guide manufacturers in selecting the appropriate conformity assessment route, whether it involves self-certification or requires involvement from a Notified Body. We can assist you in determining what is missing from your technical file and what has to be updated, as this is the transition period from IVDD to IVDR. Here are the major modifications to be aware of when submitting your IVD device to the EU market, as well as the areas where we, the IVDR CE marking consultants, can assist you:

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.
CE Marking consultants assist with device labeling to meet the specific requirements of the IVDR, ensuring that all information is clearly presented.
Performance Evaluation – required throughout the lifetime of the device, must be performed as per the 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).

Looking for some help to construct Medical Device Technical Documentation as per MDR / IVDR? Contact us! We are CE Marking Consultants. We have the experienced professionals and writers.

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Frequently Asked Questions

How long does it take to obtain CE marking under MDR/IVDR? Does CE Marking consultants help receive CE Marking faster?

The timeline can vary widely depending on the complexity of the device and its models/variants, the amount of clinical data available, the classification of the device, and the readiness of the technical documentation. Generally, it can take anywhere from 10 months to over 14 months.

How does a Medical Device CE Marking consultants helps demonstrate compliance with GSPR?

CE Mark Consultants make sure they document and provide comprehensive evidence that the device meets the GSPR listed in Annex I of the MDR or IVDR. This includes clinical data, labelling, post market activities, technical documentation, and risk management strategies.

Can we use existing data from the MDD or IVDD for MDR/IVDR compliance?

Existing data may be used after critically evaluated and justified under the new regulations by CE Marking consultants. The data must be current, relevant, and sufficient to meet the higher standards set by MDR and IVDR. Often, additional data or updated analyses is required.

Is it easy for MDR/IVDR CE certification for legacy devices? What is the process

It’s not easy to convert legacy device CE Marking to MDR CE Marking.

Devices CE marked under the previous directives (MDD or IVDD) may continue to be placed on the market under certain conditions, but they must complete the transition to full compliance with MDR/IVDR by the deadlines set in the regulations. This requires updating technical documentation and clinical evaluation report meet the new regulation

Does CE Marking consultants like I3CGLOBAL prepare the technical documentation or just guide us?

The I3CGLOBAL team guides and develops the technical file for the manufacturer. We also take responsibility for the technical file revision and updations until CE marks approval from the Notified Body is granted.

How do you assure the data integrity and misuse of confidential information

We are IEC 27001 certified for data security. Our team comprises full-time technical consultants, and we do not outsource activities to third-party individual professionals. These in-house systems assure customer property.

Do you company provide turnkey CE Marking consultation service?

Yes. the following services are covered in our scope.

Documentation
Testing (Biocompatibility and electrical)
EU Representative
Performance testing (a few types of devices)
Transport Validation (Limited scope)
Shelf life studies (Limited scope)
Packing Validations (Limited scope)
EUDAMED Registration
Clinical Evaluation
Risk Analysis
Usability studies

What are the post-market obligations under MDR and IVDR?

Medical device MDR /IVDR Post-market obligations mainly focus on the following areas

- Post-Market Surveillance (PMS): Ongoing monitoring of the device’s performance.
- Periodic Safety Update Report (PSUR): For higher-risk devices, (IIa/IIb/III) this report summarizes the results and conclusions of the PMS data.
- Vigilance Reporting: Immediate reporting of any serious incidents or safety issues to the relevant authorities and Notified Body.