Budget and Compliance: The True Cost of a Medical Device Project in Europe

Launching a medical device project in Europe means entering a journey that is as demanding as it is lengthy and costly. Behind every CE mark lies a financial reality and timelines often underestimated by project sponsors, especially startups and SMEs.

From implementing the quality management system to post-market surveillance, let’s break down the essential expenses to anticipate and plan your regulatory compliance project effectively.

Key Cost Areas

Developing and bringing a medical device to market involves a set of regulatory-related expenses at every phase of the project. With the increasing stringency of regulations, these costs have risen significantly. They primarily concern five key areas:

• Preparation of the technical documentation;
• Implementation and management of a Quality Management System (QMS);
• Post-market surveillance (PMS/PMCF);
• Conformity assessment by a Notified Body;
• Clinical evaluation.

Each of these areas plays a crucial role in the project’s success and in achieving CE marking or FDA approval.

Technical Documentation

The technical documentation is the regulatory backbone of the medical device. Its purpose is to demonstrate that the product is safe, effective, and compliant with all applicable requirements. It includes:

• General description of the product and its variants;
• Design, development, and manufacturing specifications;
• Risk analysis and management;
• Conformity strategy;
• Clinical evidence and performance data;
• Test protocols and results;
• etc.

Preparing this file requires a significant share of internal resources and often external specialists, making it one of the most expensive parts of the project. The cost of quality is estimated at 9.4% in the health industry [1].

There’s no golden rule to calculate this cost—it varies widely depending on the device’s characteristics. Estimates range from ~€30,000 for class I and II devices to €50,000+ for class III devices [2]. These costs are primarily personnel-related (employees and/or consultants), which also implies a significant time investment.

Generally speaking, expect to invest €30,000 to €50,000 and 6 to 18 months to prepare the technical documentation.

Quality Management System (QMS)

Compliance also requires implementing a Quality Management System aligned with ISO 13485. This entails investing in:

• Process documentation and maintenance;
• Process application and monitoring;
• Staff training.

A compliant QMS must cover:

• Document and record control;
• Supplier management;
• Design and development procedures;
• Verification and validation;
• Internal audits;
• Non-conformities and CAPA management;
• Traceability and complaint handling;
• etc.

Companies without such a system must invest in documentation, training, and sometimes external consulting. These costs typically range from €15,000 to €50,000+, over 6 to 18 months. Certification by an accredited body (optional) can add another €5,000 to €20,000 over three years.

Post-Market Surveillance (PMS/PMCF)

Under MDR, post-market surveillance is a strategic requirement. It involves proactive activities such as:

• Systematic collection of product usage data;
• Analysis of user feedback and incidents;
• Updates to the Periodic Safety Update Report (PSUR);
• Possible PMCF studies.

These activities must be documented in a structured PMS/PMCF plan and updated regularly. Long-term resources are required, often supported by digital tools. Initial budgets typically start at €10,000 but can grow significantly over time.

Notified Body Conformity Assessment

Only applies to class IIa, IIb, and III devices

For class IIa, IIb, and III devices, a Notified Body must assess conformity. This includes:

• Technical file review;
• QMS audits;
• Targeted inspections depending on the compliance strategy (Annex IX, X, or XI).

Notified Bodies—few in number and in high demand since MDR’s implementation—apply variable rates. The IAF estimates total audit duration ranges from 3 days (1–5 employees) to 25 days for companies with up to 10,000 employees [3]. With daily audit rates of ~€2,200 [4], costs for the first year typically range between €15,000 and €60,000, with half that amount in subsequent years.

Clinical Evaluation

Clinical evaluation is central to demonstrating a device’s safety and performance. It relies on:

• Existing clinical data (equivalence, literature);
• Clinical investigations if data is lacking;
• Benefit-risk analysis;
• The Clinical Evaluation Report (CER).

The required level of evidence depends on the device’s type and whether an equivalent exists. For devices with valid comparators, costs remain moderate—between €10,000 and €50,000 if data is well-organized.

For innovative, non-equivalent devices, full scientific demonstration of clinical benefit is required. This entails multicenter clinical studies, with costs potentially exceeding €300,000.

Conclusion

Launching a medical device project in Europe means navigating a complex and demanding regulatory landscape. While CE marking offers clear advantages — market access, regulatory credibility, and patient safety — its associated costs must not be underestimated. See our article on the topic.

Beyond internal labor, the most significant burdens come from the MDR’s reinforced requirements — technical documentation, QMS, clinical evaluation, and post-market surveillance.

Here’s a realistic estimate of total regulatory compliance costs in Europe:

Device Class	Estimated Cost Range	Average Project Duration
Class I	€50,000 to €100,000	6 to 12 months
Class IIa / IIb	€100,000 to €250,000	12 to 24 months
Class III / Innovative	€250,000 to €500,000+	18 to 36 months

These figures include the technical file, QMS, audits, clinical evaluation (excluding long studies), software tools, and internal/external resource mobilization.

For startups and SMEs, these costs often represent 5% to 10% of their annual revenue and may act as a barrier to entering the European market. That’s why it’s essential to anticipate these investments early, surround yourself with experts, and optimize resources through digitalization and strategic planning.

And that’s precisely why Gordios exists.