Medical Device (MD) and IVDD regulations
Make a success of your CE marking
Why ensure regulatory compliance for medical devices?
European Regulations (EU) 2017/745 (MDR on Medical Devices) and (EU) 2017/746 (IVDR on In Vitro Diagnostic Medical Devices) aim to enhance patient safety, device performance and market surveillance. They impose strict requirements on manufacturers to ensure a high level of quality and traceability.
Our services enable manufacturers to:
- Define the applicable regulatory scope
- Secure the design through pre-qualification analyses
- Optimise qualification and production costs
- Ensure compliance with MDR and IVDM regulations.
- Obtain CE marking and access European and international markets.
- Validate critical manufacturing processes (transport, packaging, tropicalisation, harsh environments).
- Train teams in regulatory and standard requirements.
- Implement recurring series testing during manufacturing
- Prepare clinical evaluations
Main requirements of RDM and RDM DIV regulations.
Device classification
- MDD: Devices are classified into classes I, IIa, IIb and III according to their intended use and level of risk.
- iVDD: Four classes A, B, C and D, depending on the intended use, with a significant increase in controls (90% of IVDDs require assessment by a Notified Body, compared with 15% previously).
General Safety and Performance Requirements (GSPR)
Compliance with current standards in terms of :
- Risk management according to ISO 14971.
- Basic safety and essential performance.
- Electromagnetic compatibility/Radio
- Justification of hazardous substances and consideration of cybersecurity.
Clinical and performance evaluation
- MD: Obligation to provide solid clinical data (studies, literature, etc.).
- IVDD: Validation of analytical and clinical performance.
Quality management system (ISO 13485)
- Implementation of a compliant quality system covering design, production and post-market surveillance.
- Appointment of a Person Responsible for Regulatory Compliance (PRRC).
Technical documentation and declaration of conformity
- RDM and RDM DIV technical file** with a description of the device, design, risk analysis, test reports, labelling and user documentation.
- EU Declaration of Conformity attesting to compliance with regulatory requirements.
Registration and traceability (EUDAMED, UDI)
- Registration of devices and economic operators in EUDAMED.
- Allocation of a Unique Identifier (UDI) for each device.
Post-market surveillance and vigilance
- Implementation of a post-marketing surveillance plan (PMS).
- Periodic safety reports (PSUR) and reinforced vigilance.
Tests required for compliance
The conformity assessment stage is essential for manufacturers. The choice of laboratory to assess the conformity of medical devices requires technical and normative skills in many fields.
Basic safety and performance
- Verification of electrical, mechanical, fluid and performance risks
- Compliance with IEC 60601-1 (DM) and IEC 61010-2-101 (IVDD) standards.
Electromagnetic compatibility (EMC)
- Emission and immunity tests to guarantee reliability.
- Applicable standards: IEC 60601-1-2 (DM) and IEC 61326-2-6 (IVDD).
Performance testing
- Verification of measurement accuracy and reproducibility.
- In vitro and in vivo tests for diagnostic performance.
Environmental and reliability testing
- Climatic (temperature, humidity) and mechanical (vibration, shock) tests.
- Checking the robustness and lifespan of the device.
Talk to our experts in CE marking for your DM and IVD DM
Biocompatibility and biological safety (ISO 10993)
- Cytotoxicity, irritation and systemic toxicology tests to assess the biocompatibility of materials in contact with the human body.
Cybersecurity and embedded software
- Validation of medical software according to IEC 62304, IEC 82304
- Cybersecurity risk assessment (IEC 81001-5-1).
Access to international markets
In addition to European conformity, we make it easier to export devices thanks to :
- CB Schemes: International recognition of tests.
- FDA clearance (510(k)) for the US market.
- Specific certifications for over 50 countries
Training and regulatory support
We offer specialised training courses to help you master regulatory and standards requirements:
- IEC 60601: General safety requirements
- IEC 60601-1-2: EMC construction rules
- ISO 14971: Risk management applied to medical devices.
- IEC 62366-1 : Fitness for use and ergonomics of devices.
- IEC 62304: DM software
- Requirements according to RDM and RDM DIV
Why choose the expertise of the Emitech Group?
Our services cover the entire life cycle of medical devices:
- Regulatory support and compliance matrix.
- Carrying out laboratory and in situ tests
- Helping to optimise the cost of qualification and production
- Our recognised technical expertise in all areas of medical devices and IVDs (from implants to machines)
- Accelerated access to international markets.
Related Services
Needs
Discover a selection of additional resources that explore topics related to this page including regulatory contexts, technical articles, and specific areas of expertise. These materials provide further insight to help you better understand the key challenges and available solutions.
Contact us for a quote
Do you need support to ensure the compliance of your medical devices? Contact our experts for a tailored solution.
Request a quote now
