The route to market for medical devices and IVDs

What you get

Technical documentation under Annexes II and III of Regulation (EU) 2017/745 (MDR) or Regulation (EU) 2017/746 (IVDR). Either we review what you have and advise, or we write it.

For the Annex II technical documentation, we work on:

• the device description and specification, including variants and accessories, the intended purpose, the intended users and patients, the classification rationale, the unique device identification (UDI) and the reference to previous and similar generations;
• the information supplied by the manufacturer, including labels and instructions for use;
• design and manufacturing information: design stages, manufacturing processes and validation activities;
• the general safety and performance requirements (GSPR);
• the benefit-risk analysis and the risk management file;
• product verification and validation, including the compilation of pre-clinical and clinical data: biocompatibility, electrical safety, software verification and validation, stability and shelf life, performance and safety testing, and the clinical evaluation.

For the Annex III technical documentation, we work on the post-market surveillance (PMS) plan, with its data sources, methods, indicators and thresholds, and on the report that follows from it. For devices under the MDR, that is a post-market surveillance report for class I and a periodic safety update report (PSUR) for class IIa and above.

Labelling and instructions for use, including electronic instructions for use and the UDI carrier, are reviewed as part of this work.

Clinical evidence. A state-of-the-art review of the scientific, clinical and technical knowledge for your device type. The clinical evaluation under Annex XIV of Regulation (EU) 2017/745: the clinical evaluation plan, the literature search protocol and the clinical evaluation report (CER), with one review round. Later, an update that uses post-market surveillance and post-market clinical follow-up (PMCF) data.

Inside the CE-marking programme we also cover risk management and usability (EN ISO 14971, EN IEC 62366-1), with cybersecurity work for software; the pre-clinical and biological evaluation (ISO 10993 plan for hardware; pre-clinical and clinical strategy for software); for an IVD, the IVD performance evaluation; and the draft EU Declaration of Conformity.

How the pieces fit

The state-of-the-art review comes first because it benchmarks the design and shapes the clinical evaluation strategy or, for an IVD, the IVD performance evaluation strategy. Risk management, usability and pre-clinical evaluation are done inside the CE-marking programme.

For software, the documentation follows the software lifecycle according to IEC 62304. We are used to working with Agile teams.

We are not a laboratory. We can write verification and validation plans, for example the biological evaluation plan, but the testing is always done by external laboratories.

The dates for this step depend on the class, on how many devices or variants the file covers, on whether clinical data already exist and, for software, on how much of the lifecycle is documented. We set them with you in the regulatory strategy.