In-house manufacturing of medical devices as a path to innovation

¿Sabías que puedes usar tus desarrollos internos en la práctica clínica para recopilar más datos clínicos en entorno real de utilización? El artículo 5.5 del MDR e IVDR permite una etapa intermedia perfecta para generar más evidencia clínica robusta antes de una posible comercialización.

Why do hospitals need this strategy?

In an environment where hospitals, research centers, and laboratories are increasingly developing their own solutions, the concept of the in-house manufacturer has gained extraordinary relevance. However, many institutions are unaware that a specific regulatory pathway exists allowing them to use their internal developments internally without the complexities of commercialization.

Strategic Benefits for Institutions:

• Direct impact on patients: Allows technological developments to be transferred directly to patient care without commercial barriers.
• Opportunity identification: Enables institutions to discover and evaluate which developments could provide great public benefit, identifying ideal candidates for future commercialization.
• Real clinical practice: Offers the opportunity to test and refine solutions in a real clinical environment before deciding on their commercial potential.

Regulation (EU) 2017/745 (MDR) and 2017/746 (IVDR), in Article 5.5, allow health institutions to manufacture products for internal use under specific conditions.

Ambit Iberia encourages this practice among hospital institutions as a smart intermediate step before commercial manufacturing, allowing more user data and clinical evidence to be collected.

What is considered "In-House Manufacturing"?

The MDR and IVDR, in their identical Article 5.5 in both regulations, allow certain health institutions to manufacture products for their own use without needing to comply with all commercial obligations of a traditional manufacturer.

Key condition: Only if the product is not commercialized or transferred to other entities, and if a series of strict requirements regarding safety, documentation, traceability, and justification are met.

This model applies, for example, to:

• Clinical laboratories developing in-house diagnostic kits.
• Teams programming their own software for internal medical use (SaMD).
• Centers developing specific devices for internal procedures.
• Hospitals manufacturing products for specific patient needs.

Regulatory pathway for In-House manufacturers

1. Product Classification

Even if not commercialized, the product must be classified just like any other device:

• MDR: Class I, IIa, IIb, or III
• IVDR: Class A, B, C, or D

Classification directly impacts technical, clinical, and quality requirements.

2. Technical Documentation

Here arises the first major difference:

• Commercial manufacturer: Must submit documentation to a notified body (Class IIa, B, or higher).
• In-house manufacturer: Must have documentation available, but does not require external evaluation.

Both types of manufacturers must have documentation that includes:

• Design, manufacturing, and performance
• Risk assessment (ISO 14971)
• Product verification and validation
• Traceability and reasonable clinical justification

3. Clinical Evaluation / Performance Evaluation

Justification of the expected clinical benefit is required:

• MDR: Clinical evaluation with documented reasonable justification.
• IVDR: Performance evaluation with documented reasonable justification.

Key difference: Commercial manufacturers need a full clinical evaluation + CER (Clinical Evaluation Report) + PMCF (Post-Market Clinical Follow-up). In-house manufacturers can justify based on prior experience, literature, or internal validation, provided it is well documented.

4. Verification, Validation, and Labeling

There are no shortcuts here: Technical requirements are the same for both types of manufacturers.

Both in-house and commercial manufacturers must comply with:

• Product validation according to its intended use.
• Verification ensuring it meets functional requirements.
• Labeling in compliance with Annex I requirements (safety and performance).

The difference lies in what is NOT required for in-house manufacturers:

• ❌ CE marking
• ❌ UDI or registration in databases

Note: Labeling is not intended for an open market, but for a controlled environment; however, it must exist and comply with Annex I requirements.

5. Quality Management System

Comparison of required quality systems:

• Commercial manufacturer: ISO 13485 certified by a notified body.
• In-house manufacturer:
  • MDR: Documented system (not certified)
  • IVDR: Documented system + ISO 15189 certified laboratory

Both types of manufacturers must implement written procedures for manufacturing, control, and vigilance, guaranteeing traceability and records archiving.

Additional Article 5.5 requirements: Justification of specific unmet needs, public declaration by the health institution, information provided to competent authorities upon request, and clinical experience monitoring with corrective actions.

Fabricante In-House vs. Comercial: Diferencias ClaveIn-House vs. Commercial Manufacturer: Key Differences

Why start with an In-House product?

Compared to direct commercial manufacturing, in-house manufacturing offers key strategic advantages:

• • In-house: Allows clinical data collection in real use before scaling.
  • Commercial: Requires full clinical evidence from the beginning.
    
    
  💰 Reduced Costs:
  • In-house: Avoids certification costs and notified body fees.
  • Commercial: High initial investment in certifications and staff.
    
    
  🔄 Rapid Iteration:
  • In-house: Rapid changes without recertification.
  • Commercial: Modifications require regulatory processes.

• 📊 Robust Clinical Data:
  • In-house: Real-world evidence strengthening future commercialization.
  • Commercial: Must demonstrate efficacy prior to launch.

Strategic Advantage: In-house manufacturing can serve as the perfect step prior to a future commercial launch. Regulatory work completed is not lost: it evolves and converts into a full technical file when the product is ready for the market.

The reality: It is not a free pass from obligations

Although manufacturing medical devices in-house may seem simpler than the commercial route, both approaches require regulatory rigor:

In-house vs. commercial manufacturers – Both require:

• Clear and defined organizational structure
• Documented scientific and technical evidence
• Full process traceability
• Vigilance and tracking system
• Solid and updated clinical justification

The main difference lies in additional requirements:

• In-house manufacturers: Comply with the 8 conditions of MDR / 9 conditions of IVDR (Article 5.5).
• Commercial manufacturers: Comply with all commercialization requirements (notified bodies, certifications, etc.).

Both types must comply with GSPR in Annex I (MDR/IVDR).

 ✅ Requirements applying to both:

• General safety and performance requirements
• Labeling according to Annex I Section 23 (MDR) / Section 20 (IVDR)*
• Risk management
• Internal traceability
• Instructions for use when necessary

Note: Annex I labeling includes essential information such as product name, manufacturer, expiration date, storage conditions, warnings, etc., but specifically excludes UDI and CE marking.

 ❌ Requirements exempt ONLY for in-house:

• CE marking
• UDI (Unique Device Identification)
• Eudamed registration
• Evaluation by a notified body
• Submission of technical documentation to notified bodies

The good news: If you start with in-house manufacturing, you can scale toward the commercial market with confidence. Completed regulatory work is leveraged and expanded—it is not lost.

Specific conditions of Article 5.5

For MDR (8 conditions):

1. No transfer to other legal entities.
2. Appropriate quality management systems.
3. Justification of needs not met by commercialized products.
4. Information provided to competent authorities upon request.
5. Public declaration by the health institution.
6. Detailed documentation for authority evaluation.
7. Manufacturing in accordance with documentation.
8. Monitoring and corrective actions.

For IVDR (9 conditions):

The same 8 conditions as MDR + an additional condition:

• Health institution laboratory compliant with ISO 15189 certification.

Your next step toward innovation 

Article 5.5 of the MDR/IVDR is not just a regulatory option: it is an innovation strategy that can transform how your institution develops and validates medical devices.

In-house manufacturing or direct commercialization? The answer depends on your context:

• Start in-house: Ideal for testing concepts, reducing risks, and gathering evidence.
• Scale to commercial: When you have robust data and are market-ready.

In both cases, understanding requirements and developing the right strategy from the beginning is crucial for scaling when ready.

Regulatory basis

Recital 30 of the MDR states that "health institutions should have the possibility of manufacturing, modifying and using devices in-house and thereby addressing, on a non-industrial scale, specific needs of target patient groups".

This provision recognizes that innovation within health institutions is essential to address specific clinical needs that cannot be satisfied by commercial products.

Start innovating

Article 5.5 of the MDR/IVDR represents a unique opportunity for health institutions seeking to innovate without the initial complexity of commercial manufacturing.

Compared to direct commercial manufacturing:

• In-house manufacturing offers a lower regulatory barrier to entry.
• Allows real clinical practice in a controlled environment before commercializing.
• Provides robust evidence strengthening future commercial files.
• Maintains all essential safety requirements.

The key lies in seeing both approaches as complementary, not mutually exclusive. In-house manufacturing can be the smart stepping stone toward successful commercialization, strictly complying with established conditions and maintaining necessary documentation and traceability from day one.  If you need support, contact us.

At Ambit Iberia, we have been experts for over 20 years in developing IT strategies and solutions. We help the pharmaceutical, medical device, and IVD (in vitro diagnosis) medical device sectors comply with regulations throughout the product lifecycle. We design and implement innovative infrastructures thanks to a comprehensive service offering acting as a key enabler for digital transformation.