Meet every requirement for
EU MDR

Regulation (EU) 2017/745, the Medical Device Regulation. It entered into force in May 2017 and has applied since 26 May 2021, replacing the Medical Devices Directive and the Active Implantable Medical Devices Directive. It sets out classification, conformity assessment, technical documentation, clinical evaluation, post-market surveillance and vigilance for any device placed on the EU market, and it applies to manufacturers outside the EU who sell into it.

It depends on your device class. Class I devices are generally self-declared by the manufacturer, while Class IIa, IIb and III devices need a notified body to assess your quality system and technical documentation before the CE mark goes on. Class I devices that are sterile, have a measuring function or are reusable surgical instruments need a notified body for those aspects.

The EU MDR governs the EU market and results in a CE mark. Great Britain is governed by the UK Medical Devices Regulations 2002 as amended, overseen by the MHRA, and results in a UKCA mark. The underlying expectations of a quality system, a risk file and technical documentation are close enough that the same evidence serves both, but they are separate routes and selling into both markets means meeting both.

Article 10 requires a quality management system, and ISO 13485 is the harmonised standard used to demonstrate one. It is not named as a legal requirement in its own right, but a notified body will expect a compliant QMS for anything above the lowest risk class, and building to ISO 13485 is the cleanest way to evidence it.

Annex I requires a risk management system established, documented and maintained across the whole lifecycle of the device, with risks reduced as far as possible and residual risk judged acceptable against the benefit. ISO 14971 is the standard used to demonstrate that, and Assuric holds the risk file alongside the quality system rather than in a separate tool.

Clinical evaluation is how you show, using clinical data, that your device is safe, performs as intended and has benefits that outweigh its risks. Every device under the EU MDR needs one. It is documented in a clinical evaluation report and kept up to date across the life of the device.

A post-market surveillance plan and system, a periodic safety update report or a post-market surveillance report depending on class, trend reporting, and vigilance reporting of serious incidents and field safety corrective actions to the competent authorities. The obligation applies across all classes, and the depth and frequency scale with classification.

Assuric holds your ISO 13485 quality system, your ISO 14971 risk file and the design records behind your technical documentation in one place. A record written once counts across ISO 13485, IEC 62304 and the MDR. Our regulatory team can also work with you on your clinical evaluation.

Your data is stored in the EU, in Belgium. Customer data is not used to train models.