CE Marking,
MDR and IVDR
Comprehensive regulatory support for the commercialization of medical devices and in vitro diagnostic medical devices (IVDs) in Italy and across the European Union.
CE marking is an essential requirement for placing medical devices and in vitro diagnostic medical devices (IVDs) on the European market. The introduction of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) has established more stringent requirements regarding technical documentation, clinical evaluation, post-market surveillance, and risk management.
TentaConsult Italia supports companies operating in the medical and healthcare sectors throughout the entire regulatory pathway, from the initial product assessment to the management of all activities required for commercialization in Italy and the EU.
We support:
- Medical device manufacturers
- IVD manufacturers
- Importers and distributors
- Healthcare and life sciences companies
- Medical and biomedical startups
- Medical software manufacturers and SaMD developers (Software as a Medical Device)
MDR and IVDR Consulting Services
Compliance with the MDR and IVDR extends far beyond the preparation of regulatory documentation. It requires a well-defined regulatory strategy aligned with the device type, target market, and risk classification.
TentaConsult Italia adopts a practical, operational approach aimed at:
- Simplifying the compliance pathway
- Reducing regulatory timelines and potential challenges
- Improving the quality and robustness of technical documentation
- Supporting interactions with Notified Bodies
- Facilitating access to the European market
Our consulting activities are carried out in close collaboration with the client's technical, quality, and regulatory teams.
Technical Documentation Gap Analysis
We assess existing documentation to identify any gaps against MDR and IVDR requirements.
Our activities include:
- Regulatory compliance assessment
- Device classification review
- Evaluation of General Safety and Performance Requirements (GSPR)
- Technical documentation completeness review
- Identification of regulatory and documentation gaps
The objective is to establish a clear and sustainable regulatory strategy while minimizing risks, delays, and challenges throughout the certification process.
Technical Documentation Preparation
We support the preparation and updating of technical documentation required under the European MDR and IVDR regulations.
Services may include:
- Technical Documentation / Technical File preparation
- Device description and specification
- Risk management documentation
- GSPR checklist development
- Labeling and Instructions for Use (IFU)
- Verification and validation documentation
- Regulatory compliance support
Documentation is developed in accordance with applicable regulatory requirements and relevant harmonized standards.
Biological Evaluation (BEP and BER)
Biological safety is a key element in demonstrating regulatory compliance for many medical devices.
TentaConsult Italia supports companies with:
- Preparation of the Biological Evaluation Plan (BEP)
- Preparation of the Biological Evaluation Report (BER)
- Assessment of available biological data
- Biocompatibility evaluation
- Support in defining the required biological evidence
Our approach takes into account the device type, intended purpose, duration and nature of contact, and the associated risk profile.
Learn more about Biological Evaluation services for medical devices
Biological evaluation is a fundamental requirement for demonstrating the safety of a medical device under the MDR and applicable ISO standards, including ISO 10993.
Discover how TentaConsult Italia supports manufacturers in the preparation of BEPs and BERs, biocompatibility assessments, and the development of the biological evidence required for regulatory compliance.
Clinical Evaluation (CEP and CER)
Clinical evaluation is one of the most critical elements of the CE marking process under the MDR, as it provides evidence of the device's safety, performance, and clinical benefit.
We provide support for:
- Clinical Evaluation Plan (CEP)
- Clinical Evaluation Report (CER)
- Literature-based clinical evaluation
- Clinical equivalence assessment
- Collection and analysis of clinical evidence
- Updating and maintenance of clinical documentation
For IVDs, our support also includes the management of scientific validity, analytical performance, and clinical performance evidence required under the IVDR.
Specialized support for CEP, CER and MDR Clinical Evaluation
A robust and well-structured clinical evaluation is essential for obtaining and maintaining CE marking.
TentaConsult Italia supports manufacturers in the development of Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), clinical equivalence assessments, literature reviews, and the collection and analysis of clinical evidence in accordance with MDR and IVDR requirements.
Post-Market Surveillance (PMS)
Under the MDR and IVDR, manufacturers are required to implement a continuous system for monitoring the safety, performance, and effectiveness of their devices after they have been placed on the market.
TentaConsult Italia supports companies in the management of:
- Post-Market Surveillance Plan (PMS Plan)
- Post-Market Surveillance Report (PMS Report)
- Post-Market Clinical Follow-up (PMCF)
- Collection and analysis of post-market data
- Trend analysis and signal monitoring
- Updating technical documentation
- Regulatory lifecycle management of medical devices and IVDs
Our services help manufacturers establish and maintain a proactive post-market surveillance system that supports ongoing compliance and continuous product improvement.
National and EU Regulatory Registrations
TentaConsult Italia assists manufacturers, importers, and distributors in managing the registrations required to place medical devices and IVDs on European markets.
Our activities include:
- National regulatory registrations
- Support for CE marking-related registration requirements
- Management of regulatory documentation obligations
- Operational support for market access activities
Technical and Regulatory Support for MDR and IVDR Compliance
Regulatory affairs activities require multidisciplinary expertise that combines regulatory, technical, clinical, and documentation-related competencies.
TentaConsult Italia provides specialized support for:
- Class I, Class IIa, Class IIb, and Class III medical devices
- Medical software and Software as a Medical Device (SaMD)
- Electromedical devices
- Substance-based medical devices
- Legacy devices transitioning to MDR compliance
- In vitro diagnostic medical devices (IVDs)
Our Process
- Preliminary Assessment
Evaluation of the device, regulatory classification, and the status of existing documentation. - Regulatory Strategy Definition
Identification of the applicable MDR or IVDR pathway and development of a structured regulatory roadmap. - Technical Documentation Development
Preparation, review, and enhancement of the technical documentation required to demonstrate regulatory compliance. - Compliance Support
Technical and regulatory assistance throughout the conformity assessment and certification process, including support in addressing regulatory and Notified Body requirements. - Post-Market Support
Ongoing documentation updates, post-market surveillance activities, and long-term compliance maintenance throughout the device lifecycle.
Do you need support for CE Marking Under MDR or IVDR?
TentaConsult Italia supports medical device and IVD manufacturers in managing European regulatory compliance, from technical documentation development and clinical evaluation to post-market surveillance and lifecycle management.
Our experts help companies navigate complex regulatory requirements and establish efficient compliance strategies for successful market access in Italy and across the European Union.
You may also be interested in
FAQ
What is CE marking for medical devices?
CE marking demonstrates that a medical device complies with the applicable European regulatory requirements and can be legally placed on the market within the European Economic Area (EEA).
What is the difference between MDR and IVDR?
The MDR (Regulation (EU) 2017/745) governs medical devices, while the IVDR (Regulation (EU) 2017/746) applies to in vitro diagnostic medical devices (IVDs). Both regulations establish requirements for safety, performance, quality, and post-market monitoring.
When is MDR technical documentation required?
Technical documentation is mandatory for all medical devices placed on the European market. It must demonstrate compliance with the applicable MDR requirements and support the device's conformity assessment process.
What is a Clinical Evaluation Report (CER)?
The Clinical Evaluation Report (CER) is a key MDR document that demonstrates the safety, clinical performance, and clinical benefits of a medical device based on available clinical evidence and data.
What are BEP and BER?
The Biological Evaluation Plan (BEP) and Biological Evaluation Report (BER) are documents used to demonstrate the biological safety and biocompatibility of a medical device in accordance with applicable regulatory requirements and standards.
What is PMS in medical devices?
Post-Market Surveillance (PMS) is the systematic process of continuously monitoring the safety, performance, and effectiveness of a medical device after it has been placed on the market.
Are national registrations mandatory?
Yes. Depending on the country where the device is marketed, national registrations, notifications, or other country-specific regulatory obligations may be required in addition to MDR or IVDR compliance.
Does TentaConsult Italia support legacy devices?
Yes. We assist manufacturers in updating technical documentation, regulatory strategies, and compliance activities for legacy devices transitioning to MDR or IVDR requirements.
Do you provide support for medical software?
Yes. TentaConsult Italia supports regulatory projects involving medical software and Software as a Medical Device (SaMD) subject to MDR requirements, including classification, technical documentation, clinical evaluation, and compliance activities.
Is it possible to request a preliminary gap analysis?
Yes. A preliminary gap analysis allows manufacturers to assess the status of their technical documentation, quality system, and regulatory compliance, identifying potential gaps and regulatory challenges before initiating a certification or compliance project.