Medical Device and IVD Documentation Services

In vitro diagnostics and medical devices carry their own demanding documentation requirements, and far fewer writers specialise in them than in drug submissions. EvySaif’s medical device and IVD documentation services prepare the performance evaluation and clinical evidence documents that Notified Bodies and regulators expect under the EU IVDR (2017/746) and MDR (2017/745), as well as India’s Medical Device Rules, with genuine hands-on IVD protocol experience behind the work.

For an IVD, performance evaluation is built on three pillars: scientific validity, analytical performance and clinical performance. We write the Performance Evaluation Plan (PEP) that sets out what evidence you will collect and how you will assess it, and the Performance Evaluation Report (PER) that synthesises the collected evidence into conclusions supporting your intended use, labelling claims and CE marking. Where clinical performance studies are needed, we prepare the Clinical Performance Study Protocol (CPSP) and Clinical Performance Report (CPR) in line with IVDR Annex XIII and EN ISO 20916:2024. Because the PER and PEP must stay aligned, since Notified Bodies query any divergence, we keep methods, acceptance criteria and data sources consistent across both.

Each of the three pillars answers a different question, and your evidence has to satisfy all three before the PER conclusions hold together.

Scientific validity establishes that the analyte you measure is genuinely associated with the clinical condition or physiological state your device targets. The evidence here usually comes from peer-reviewed literature, consensus or guideline documents, and proof-of-concept data. We run a structured literature search and appraise the sources so the link between analyte and condition is documented, not assumed.

Analytical performance shows that the device correctly and reliably detects or measures the analyte. This is the bench-level evidence set out in IVDR Annex I, Section 9.1, and it typically covers trueness and precision, analytical sensitivity and specificity, limit of detection and quantitation, measuring range and linearity, cut-off, and the cross-reactivity, interference and stability studies that prove the result holds up in real conditions. We turn your validation study outputs into a clear analytical performance report tied to defined acceptance criteria.

Clinical performance demonstrates that the device yields results correlated with the target clinical condition in the intended population and the intended user, the definition IVDR sets out in Article 2. The metrics here are diagnostic sensitivity and specificity, positive and negative predictive values, and likelihood ratios. Where existing data is insufficient under IVDR Annex XIII, Section 1.2.3, a dedicated clinical performance study may be required, and we prepare the Clinical Performance Study Protocol and Clinical Performance Report to ISO 20916:2024 for that purpose.

Performance evaluation does not stop at CE marking. We also prepare the Post-Market Performance Follow-up (PMPF) plan and report that keep the evidence current across the product lifecycle, which for Class C and Class D devices must be updated at defined intervals.

This is where EvySaif’s experience is most concrete. We have delivered clinical and analytical performance protocols for a full range of in vitro diagnostic instruments and consumables, including glucose and haemoglobin testing systems, for both Indian and EU markets. IVD documentation is a niche where specialist, regulator-aware writing is hard to find, and it is an area we know first-hand.

The shift from the old IVD Directive (98/79/EC) to the IVDR (2017/746) is the biggest reason demand for this documentation has grown. Under the old Directive most IVDs were self-certified by the manufacturer. Under the IVDR’s risk-based classification (Class A to D), the large majority now require Notified Body involvement, which means a full performance evaluation file rather than a self-declaration. Many legacy products have also been up-classified, so a device that needed little documentation before may now need a complete PEP, PER and supporting performance reports.

Regulation (EU) 2024/1860 extended the transition deadlines for legacy devices, giving manufacturers more time, but the documentation still has to be built. The current legacy transition dates run to December 2027 for Class D, December 2028 for Class C, and December 2029 for Class B and Class A sterile devices, with an IVDR-compliant quality management system required from 26 May 2025. If you are transitioning a legacy IVD, we can help you assemble the performance evaluation documentation the new framework requires. (Always confirm your specific deadline against the current Commission guidance, since conditions apply per device.)

Performance Evaluation Plan (PEP) and Performance Evaluation Report (PER) under IVDR
Clinical Performance Study Protocols (CPSP) and Clinical Performance Reports (CPR)
Analytical and clinical performance protocols for India and EU markets
Scientific validity reports based on literature or in-house data
Post-Market Performance Follow-up (PMPF) plans and reports
Clinical Evaluation Reports (CERs) for medical devices under MDR (2017/745)
Instructions for Use (IFU), package inserts and Quick Reference Instructions

IVD and medical device manufacturers, diagnostics start-ups transitioning from IVDD to IVDR, companies pursuing CE marking or Indian CDSCO device approval, and device CROs needing specialist documentation support.

EvySaif stands among the best research and medical writing consultancies in India. Few medical writing consultancies genuinely understand IVDs, since most are drug-focused. We bring real protocol delivery experience, a clinician’s grasp of how a diagnostic result drives clinical decisions, and documentation written to withstand Notified Body scrutiny. For manufacturers in India and the GCC, we pair that with international-standard writing at consultancy pricing.

What is the difference between a DSUR and a PSUR or PBRER?

A DSUR covers an investigational product during clinical development (ICH E2F). A PSUR or PBRER covers a marketed product's periodic benefit-risk evaluation after approval (ICH E2C(R2)). They share a purpose but apply at different lifecycle stages.

Do you write patient safety narratives?

Yes, for serious adverse events, SUSARs and deaths, either standalone or as part of an aggregate report or CSR.

Can you prepare a Risk Management Plan?

Yes. We author RMPs covering the safety specification, pharmacovigilance plan and risk-minimisation activities.

Which authorities do you write for?

FDA, EMA, CDSCO and Middle East regulators, with reports structured to the relevant ICH guidance and any region-specific annex requirements.