Medical Device Manufacturer: The Starter Pack

Introduction – From Idea to Compliance: A Path to Map Out

A breakdown of the key steps future medical device manufacturers must address before placing their products on the European market.

There’s only a short step from idea to project, but to prevent that project from stalling, future manufacturers must prepare carefully and know what lies ahead. Between the innovative concept and market launch, the industrial journey follows a precise and demanding regulatory framework set by Regulation (EU) 2017/745 (MDR).

Understanding the key stages and anticipating the obligations imposed by Regulation (EU) 2017/745 (MDR) is the best way to turn compliance into a strategic advantage.

Identify your role and the device class

Medical Device or Not?

First things first: what is (or will be) your product? Which category does it belong to? The question may seem simple, but it’s crucial. Why? Because if your product is not a medical device within the meaning of the MDR – or does not fall within the list of products in Annex XVI – then this article does not apply to you.

To verify this, see our article What Is a Medical Device? which details the qualification criteria under the MDR.

Your role under the MDR

Once the nature of the product has been confirmed, you must determine your role under the MDR. The regulation distinguishes several economic operators:

• the manufacturer
• the authorised representative
• the importer
• the distributor

Each has its own specific obligations.

According to the MDR, the manufacturer is the natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark.

If this definition does not fit your situation, you can stop here. The rest of this article does not concern you.

Once your role is clear, it’s time to assess your device’s risk class.

Classifying the Device: A Strategic Step

Now that your role is confirmed, you must determine the classification of the device according to Annex VIII of the MDR. This is a strategic step: the device class (I, IIa, IIb, or III) determines:

• the conformity assessment route (Annexes IX, X, XI, and XIII)
• the need for a Notified Body
• the extent of documentation required

Advice: document your classification rationale. The justification for each rule applied is expected in the device’s technical documentation and will be reviewed by the Notified Body.

Choosing a notified body

For class I devices, you do not need a Notified Body (NB). You will carry out self-certification by drafting an EU Declaration of Conformity confirming that both your device and your organisation comply with all applicable MDR requirements.

While this process is administratively lighter, it still requires a complete and consistent technical documentation package, ready to be presented to any competent authority upon request.

For devices of higher classes, you must select an NB to certify your product. Don’t delay: the number of NBs designated under the MDR remains limited, and certification timelines can extend to 18 to 24 months.

Advice: prepare your documentation in English. This will widen your options and prevent you from being limited to local NBs.

For more information, see our article The Role of Notified Bodies.

Implement a quality management system

Key Requirements

The Quality Management System (QMS) forms the backbone of a manufacturer’s compliance. It defines how the company organises, controls, and documents its activities to ensure that its devices continuously meet the requirements of the MDR.

The MDR requires a documented QMS covering a wide range of activities, including:

• regulatory strategy
• design and development
• clinical evaluation
• risk management
• resource management
• production and control
• traceability (including the UDI system)
• vigilance
• post-market surveillance (PMS)
• and more

Advice: A well-structured QMS from the start helps avoid the painful reconstruction of compliance evidence at the end of development.

When your product certification depends on a Notified Body (NB), it will verify not only that your QMS meets MDR requirements, but also that it is effectively implemented in routine practice.

Toolset

The ISO 13485:2016 + A11:2021 standard is the benchmark for implementing a QMS aligned with the MDR. Although not mandatory, it is harmonised, meaning that compliance with this standard ensures conformity with most MDR QMS requirements.

In practice:

• NBs generally offer certification to this standard
• It’s also possible to have your QMS certified by an accredited third-party organisation independent of your NB

For more details, see our article ISO 13485 vs MDR: Complementarity or Complexity?

Advice: implementing an effective QMS depends as much on the tools as on the processes. A digital, collaborative document system simplifies traceability, coherence, and control of quality records.

Build the technical documentation of the device

The technical documentation – often referred to as the technical file – lies at the heart of the CE marking process. This is where the manufacturer provides evidence of compliance with all MDR requirements.

It brings together the results of multiple activities:

• design
• manufacturing
• risk management
• clinical evaluation
• verification & validation
• post-market surveillance
• etc.

This documentation is not a static deliverable at the end of the project. It must be established early in development and kept up to date throughout the device’s lifecycle. Each modification must be traceable.

This documentation is not a simple and isolated document. It serves as the convergence point of many of the manufacturer’s activities, which feed into each other and must evolve in a consistent manner.

The technical file is a reflection of the QMS itself by translating the manufacturer’s overall control over the entire life cycle of the device.

The structure of the technical documentation is not fully fixed and may vary slightly from one Notified Body to another. Annex II of the MDR specifies the minimum content:

• description and specifications of the device
• information on design and manufacturing
• General Safety and Performance Requirements (GSPR)
• verification and validation
• clinical evaluation
• post-market surveillance

For more details, see our article MDR Technical Documentation: Requirements and Practical Challenges.

Advice:

• Start structuring your technical file early in development
• Centralise documentation in a reliable, collaborative system (e.g. Certeafiles)

Plan ahead and don’t underestimate the necessary resources

Bringing a medical device to market is a multidisciplinary project. You will need expertise in:

• Design & Development: transforming the idea into a functional, safe device (key for risk management)
• Quality: establishing, maintaining, and enforcing the QMS and promoting good working practices
• Regulatory Affairs: identifying and interpreting applicable requirements (regulations, standards, guidance) and appointing the Person Responsible for Regulatory Compliance (PRRC) as required by the MDR
• Clinical: demonstrating clinical performance and a favourable benefit–risk profile
• Marketing: understanding market needs and positioning relative to competitors (expected in the CE marking process)
• Project Management: coordinating all these activities efficiently

A well-planned organisation of activities and resources is essential to prevent delays, inconsistencies and excess costs. Examples of potential project bottlenecks include:

• risk management
• clinical evaluation (especially if clinical investigations are needed)
• biological evaluation (complex devices and higher risks can imply lengthy or costly testing)
• design and development (including prototyping, product validation, process validation, usability engineering, etc.)

Prepare your market strategy

Bringing a device to market doesn’t stop at CE marking. Commercialisation is also regulated under the MDR and by national laws. Three pillars underpin an effective marketing strategy:

• Choice of sales channels: B2B, public procurement, e-commerce, pharmacy, etc. – each with its own constraints (advertising, distribution, storage, etc.)
• Choice of partners: distributors, importers – their roles must be clearly defined to avoid compliance breaches
• Reimbursement access: depending on the country and device class, clinical and economic evaluations may be required

Advice: integrate your market and reimbursement strategy early in the design phase to align clinical performance with economic expectations.

The essential tools to get started

To manage compliance efficiently, you can rely on four complementary pillars:

• smart document management tools: centralised control, version tracking, electronic validation
• regulatory watch: continuous updates on regulations, guidance, and harmonised standards
• external expertise: quality and regulatory consultants, clinical experts, notified bodies
• internal quality culture: continuous team training on regulations and good practices

Advice: The practical implementation of these pillars is now greatly facilitated by digital tools available on the market. For example, the collaborative platform Certeafiles strengthens traceability and document consistency by centralizing information, linking it to each process, risk, or requirement, and identifying regulatory and standard updates relevant to the specific device.

These tools not only save time, but also ensure the consistency of documentation required by the MDR. Beyond the tools themselves, it is a genuine culture of quality that must be embedded within the company.

Conclusion – Think long term

Being a medical device manufacturer is far more than designing a product. It’s about building a documented, controlled, and evolving system that guarantees:

• patient safety
• clinical performance
• long-term compliance

The MDR has made the journey more demanding, but it has also helped professionalise the industry. By anticipating key requirements from the start — classification, QMS, documentation, clinical evaluation, risk management, and more — manufacturers can turn compliance into a sustainable competitive advantage.

Certeafiles: the platform that structures, automates, and secures your compliance

Starting your MedTech project?

Certeafiles digitalizes and streamlines your entire MDR compliance process:

• Automatically structured technical documentation, MDR-compliant, clear, and fully scalable
• Unified centralization of all documents, versions, and evidence of compliance
• Drastically reduced time spent preparing, managing, and maintaining documentation
• Reduced costs thanks to a hybrid digital and human model, where expert support is provided only when it brings real value
• Collaborative workspace, designed for regulatory, quality, R&D, and clinical teams
• Integrated regulatory monitoring, always aligned with the latest requirements and standards

The platform enables you to focus on innovation while securing every stage of the regulatory process.

👉 Contact us to discover how Certeafiles accelerates and strengthens your MDR compliance.