Before you start writing, you need to determine the fundamental approach: How will you demonstrate conformity using clinical data? The MDR provides several options – in particular, the equivalence route (Article 61(3), specified in MDCG 2020-5), the route via a proprietary clinical investigation (Article 61(4) in conjunction with Article 62), and the use of existing clinical data and scientific literature. Additional requirements apply to certain Class III and implantable devices. In some cases, Article 61(10), the performance data route, may be applicable if demonstrating conformity based on clinical data is not considered appropriate.

What we do:

Based on your product idea and at least its intended purpose, we analyze which route is realistic and efficient for your product – for example, whether equivalence to an existing product is viable or whether your own clinical data needs to be collected. From this, we derive your strategy, which determines the entire subsequent process. You then incorporate this into your own CEP (Corporate Efficiency Plan).

Every statement about your product – regarding safety, clinical performance, and clinical benefit – is a "claim" (also called an endpoint) that must later be substantiated with clinical data (basic safety and performance requirements according to Annex I of the MDR). For a claim to be verifiable, it needs measurable parameters against which it can be supported.

This is where important requirements come into play: Claims and measurable parameters must be derived:

From risk management and clinically relevant residual risks and, if applicable, the PMS: the safety claims (Annex XIV, Part A of the MDR)

Regarding performance (the functions, features of the product): the claims for clinical performance (MDR Article 2, point 52)

From clinical performance: clinical benefit (MDR Article 2, point 53) 

From the state of the art: the measurable parameters and also the claims (parallel to og)

What we do:

From the intended purpose, indications, and – if available – your information on similar devices, we derive the claims clearly and define the corresponding measurable parameters. This ensures clarity from the outset regarding what you need to document in the CER and how success will be measured. You provide us with your CEP (if available) or a product description including intended use, indications, and similar devices.

The state of the art describes the current state of medical knowledge: recognized treatment methods, available alternatives, relevant standards and guidelines, and comparable products. It is the reference against which the safety and performance of your product are measured – and a prerequisite for meaningful acceptance criteria. It provides data on the state of the art of the underlying technology, the underlying indications, alternative applications, and similar products. 

From this, claims regarding the safety, clinical performance, and benefits of the evaluated product can be derived.

What we do: We write the complete state-of-the-art section based on the results of your literature search and derive the claims and measurable parameters from them. You provide us with the relevant hits from your SotA search, your existing CEP, and a product description with similar devices.

Substantiating a claim means supporting each claim with reliable clinical data. This is precisely where gaps often arise, which can later lead to inquiries from the notified body. This is where the measurable parameters used to support the claims come into play.

What we do:

We assign the appropriate evidence (measurable parameters) to each claim, evaluate and analyze the data, and demonstrate transparently that each claim is covered. You provide us with CEP and CER data, including all clinical data.

The final benefit-risk assessment is the core of every clinical evaluation: it weighs the clinical benefits against the remaining risks and adverse effects and explains why the ratio is acceptable (Article 61 and the basic safety and performance requirements according to Annex I of the MDR, in particular GSPR 1 and 8).

What we do:

We will prepare the final benefit-risk assessment in the CER – consistent with your risk management (ISO 14971) and the data from PMS/PMCF. You will provide us with the risk analysis, PSUR, PMCF report, CEP, and CER along with all clinical data.

We will conduct a structured, documented literature review for you and document it with a plan, protocol and report.

What we do:

We develop and conduct the entire research process – from the search strategy and database selection to the keywords and execution. You receive a fully documented research report, including a search plan, search log, and search log. Ideal for anyone who writes their own review but doesn't want to set up the search themselves – based on the principle of "You write, we search.".

What we do:

You have already conducted your search and provide us with your results list, your search objective (search terms), the type of search (state of the art and/or product), and your CEP (Key Performance Indicator) with its claims and measurable parameters. We will then categorize the publications as relevant or irrelevant, providing a clearly documented explanation of why each publication was excluded. The result is a transparent and easily understandable Excel spreadsheet.

What we do:

We assess your existing or self-generated clinical evaluation from a medical and regulatory perspective, uncover gaps and inconsistencies, and provide specific recommendations for improvement – ​​as a preliminary assessment according to the MDCG checklist before release or submission for product approval.

You provide us with your complete clinical evaluation file (CEP, literature search documents, and CER), and we will prepare a detailed review report outlining all findings. (This does not include any corrections to the documents.) 

We will fully address the deviations and "cure" your clinical assessment to be MDR-compliant:

What we do:

We handle the entire process, analyze the complaints of the Notified Body and create or “cure” your clinical assessment in compliance with the MDR – ideal in cases of serious deviations or tight deadlines.

What we do: 

You work independently based on our verified templates, we review your results and provide targeted support at critical points – ideal for minor deviations and sufficient internal resources.