CE
Conformity with the applicable European requirements
Compliance
Quality and compliance at the centre of every solution
An approach built around quality, safety, traceability and regulatory compliance for devices and equipment intended for healthcare, diagnostic and research environments.
ISO 13485
Quality management system for medical devices
ISO 14971
Risk management for medical devices
UDI & Traceability
Device identification and traceability, where applicable
Informational references to the regulatory framework and to industry standards — they are not statements that MedNexus itself is certified.
European regulatory framework
- Regulation (EU) 2017/745 (MDR) — medical devices
- Regulation (EU) 2017/746 (IVDR) — in vitro diagnostic devices, where applicable
- CE marking, where required by the applicable legislation
- Device classification based on intended purpose and risk
- Conformity assessment procedures
- Obligations of the economic operators involved (manufacturer, importer, distributor)
Medical devices and in vitro diagnostic medical devices placed on the European Union market may be subject, depending on their intended purpose, to the applicable European regulatory framework. The main references are Regulation (EU) 2017/745 (MDR) for medical devices and Regulation (EU) 2017/746 (IVDR) for in vitro diagnostic medical devices, where applicable.
The route to conformity depends on the classification of the device, which determines the conformity assessment procedure and how far a third party is involved. CE marking, where required, is the outcome of that route — not a label applied at will.
Not every product is subject to every requirement: ancillary equipment, technical furniture, non-medical consumables or research-only instruments may fall under different frameworks. Each case therefore has to be assessed on the basis of the intended purpose stated by the manufacturer.
Quality management system
- ISO 13485 as the quality management system reference
- Control of documents, revisions and records
- Control of processes and suppliers
- Management of non-conformities and corrective actions
- Traceability of batches, supplies and distribution
- Quality assurance and internal audits
In the medical device sector, the quality management system is how an organisation makes its processes repeatable and verifiable. The international reference standard is ISO 13485, which adapts quality management principles to the specifics of the field: patient safety, control of changes and documented responsibility.
Such a system rests on concrete elements: control of documents and revisions, control of processes and outsourced activities, structured handling of non-conformities and corrective actions, traceability of batches and supplies, quality assurance activities and internal audits.
These principles are described here for information, as sector references, and are not a statement of certification by MedNexus.
Safety and risk management
- Hazard identification and risk assessment
- Mitigation measures and verification of their effectiveness
- Safety across the entire product lifecycle
- Post-market surveillance and handling of reports
- ISO 14971 as the international reference standard
The safety of a device is not verified at a single point in time: it is built and maintained across the whole product lifecycle. The process starts from hazard identification and from assessing the risks associated with intended use and reasonably foreseeable misuse, then defines mitigation measures and verifies that they are effective.
The international reference standard for medical device risk management is ISO 14971, which describes a continuous process: risk analysis, risk evaluation, risk control and review of the overall residual risk.
Once a product is on the market, post-market surveillance completes the picture: collecting and analysing information from real-world use, handling complaints and reports and, where necessary, taking field corrective actions.
Documentation and traceability
Depending on the type of product and the applicable legislation, the documentation accompanying a device may include the following elements.
EU declaration of conformity
where applicable
Applicable certificates
depending on classification
Technical documentation
held by the manufacturer
Instructions for use
in the required language
UDI identification
where applicable
Manufacturer, importer and distributor information
where applicable
Compliance
Our approach
MedNexus treats compliance not as a paperwork requirement, but as an integral part of product and service quality.
The quality of a supply does not end at delivery: it includes the accuracy of technical information, consistency between what is stated and what is delivered, and the availability of the relevant documentation at the moment it is needed. Every product page is therefore built to make technical data, identifiers and references readable, without misleading simplification.
Transparency also means stating limits. When information is unavailable, or a requirement does not apply to a given product, we say so explicitly instead of filling the gap with generic wording. That is the precondition for a buyer to make an independent, informed assessment.
Responsible distribution, finally, means maintaining traceability along the supply chain, keeping the link between product, supplier and documentation, and handling any non-conformity or report from real-world use in a structured way.
Explore the range
Every product has its own page with technical data, identifiers and availability.