The Balkan Puzzle: Using Non-EU States As A "Pre-MDR" Proving Ground For Your Device

By Julio G. Martinez-Clark, CEO, bioaccess

The European Union's Medical Device Regulation (MDR 2017/745) has fundamentally reshaped the path to market for medtech innovators. While designed to enhance patient safety, the MDR has introduced a new level of rigor that presents a formidable barrier to entry for many companies, especially early-stage startups. The regulation's demands for more extensive clinical evidence and robust quality management systems have significantly increased the costs, timelines, and regulatory burdens associated with gaining a CE mark.^1,2 For a resource-constrained startup, committing to a full MDR-compliant trial for a first-in-human (FIH) study can be a bet-the-company decision.

This high-stakes environment necessitates creative capital-efficient strategies to bridge the gap between a promising prototype and an MDR-ready device. A sophisticated, yet practical, strategy is emerging from the complex regulatory landscape of the Balkan states: leveraging non-EU countries as a "pre-MDR" proving ground. This approach allows innovators to generate crucial human data in a regulated environment without immediately incurring the full cost and complexity of the MDR, turning a potential roadblock into a strategic stepping stone.

The Great Divide: EU Vs. Non-EU Regulatory Realities

The key to this strategy lies in understanding the fundamental regulatory divide within the Balkan region. Countries are split into two distinct camps: EU member states, such as Croatia and Bulgaria, which are fully bound by the MDR, and non-EU states like Serbia, Bosnia and Herzegovina, Albania, and Montenegro, which operate under their own national frameworks.³

For medtech startups, this division creates two very different operational realities. Conducting a trial in an EU member state requires adherence to the high standards of the MDR from day one. In contrast, non-EU states offer a more accessible pathway for initial studies, though each presents its own unique advantages and challenges.^4,5

Comparing The Non-EU Balkan Landscape: Why Serbia Leads The Pack

While several non-EU Balkan states offer alternatives to the MDR pathway, Serbia has emerged as the clear leader for medtech clinical trials. A detailed comparison reveals why other options fall short:

Bosnia and Herzegovina: Regulatory Complexity Without the Benefits

Bosnia and Herzegovina presents significant operational challenges, making it less attractive than Serbia. The country's complex federal structure creates a fragmented approval process involving multiple ethics committees — five different ECs, including those at University Clinical Centers in Sarajevo, Banja Luka, Mostar, and Tuzla — each with different guidelines and timelines ranging from one to 15 months.⁶ Even after ethics committee approval, the national agency ALMBIH requires an additional five weeks, and contract negotiations can extend to four to six months, creating a total timeline of up to one and half years.⁶ This extended timeline negates the speed advantage that makes the pre-MDR strategy viable.

Montenegro: Limited Infrastructure and Market Size

Montenegro, with a population of only 628,000, offers insufficient patient recruitment potential for meaningful clinical trials. While the regulatory framework is streamlined and aligns with EU standards, the small healthcare infrastructure limits the number of qualified investigators and sites.⁷ The country still requires paper submissions for medical devices, adding administrative burden, and lacks the established clinical research ecosystem necessary for efficient trial execution.⁸

Albania: Regulatory Framework Still in Development

Albania represents the least mature option among the non-EU Balkan states. Clinical trial regulations have been part of Albanian law since 1994, but detailed implementation guidelines were only published in March 2018, and these are still being refined.⁹ The regulatory framework remains less developed compared to Serbia's established processes, and the country lacks the robust network of experienced clinical investigators and modern facilities that Serbia offers.¹⁰

Serbia: The Optimal Balance of Speed, Scale, and Sophistication

In contrast, Serbia offers a compelling combination that addresses each weakness found in its neighbors:

• Regulatory Efficiency: A streamlined approval process through ALIMS and a single national ethics committee delivers decisions within 60 to 90 days,^11,12 avoiding the multi-committee complexity of Bosnia and Herzegovina.
• Market Scale: With over 6.7 million inhabitants, Serbia provides sufficient patient diversity and recruitment potential,¹³ far exceeding Montenegro's limited population base.
• Infrastructure Maturity: Serbia has an established clinical research infrastructure with experienced investigators, modern facilities, and mandatory eSubmissions since 2018,^8,14 providing operational advantages that Albania's developing system cannot match.

The Pre-MDR Proving Ground Strategy: A Practical Road Map

The pre-MDR approach represents a form of strategic risk mitigation that savvy medtech companies are increasingly adopting. This strategy uses Serbia as the optimal non-EU Balkan state to generate the initial human data required to de-risk a technology before committing to the more demanding and expensive MDR process. Here's how the strategy unfolds in practice:

1. Acknowledge the Regulatory Reality

Companies first recognize that while the MDR is the ultimate goal for European market access, it presents too high a barrier for initial FIH or early feasibility studies. This honest assessment allows for strategic planning rather than costly regulatory struggles.

2. Select Your Strategic Proving Ground

Rather than targeting an EU country or settling for less optimal non-EU alternatives, companies choose Serbia for its superior combination of regulatory efficiency, market scale, and infrastructure maturity. Serbia's framework, governed by ALIMS and the Ethics Committee of Serbia, requires formal trial approval and adherence to Good Clinical Practice (GCP) but avoids the complexity and delays found in neighboring countries.

3. Generate Critical Human Data

Companies conduct small-scale FIH studies, typically involving 10 to 30 patients, in Serbia. The primary objective isn't market access in Serbia but gathering the first critical evidence of the device's safety and performance in a controlled, regulated environment. This data strengthens the technical file and Clinical Evaluation Report — essential components for eventual MDR compliance.

4. Approach the EU with Confidence

Armed with initial human data from a credible regulatory environment, companies are in a much stronger position when approaching an EU notified body. They've validated their technology in humans and can present a more compelling dossier for complete CE mark conformity assessment under the MDR.

This strategy transforms Serbia into a cost-effective and time-efficient stepping stone, allowing startups to build their evidence base incrementally rather than betting everything on a single expensive MDR-compliant trial.

Why Serbia Maintains Its Competitive Edge: The EU Accession Question

A critical consideration for the long-term viability of this strategy is Serbia's trajectory toward EU membership and the inevitable alignment with MDR requirements. However, this concern, while valid, overlooks several essential realities that suggest Serbia will maintain its advantages for the foreseeable future:

• EU Accession Timeline Provides Extended Window: Serbia's EU accession process remains in the early stages, with significant political and economic reforms required before membership becomes a reality. Current estimates suggest EU accession is unlikely before 2030, providing medtech companies with a substantial window to leverage Serbia's current advantages.¹⁵ Even when accession occurs, transition periods will allow continued use of current regulatory pathways.
• Graduated Regulatory Alignment Preserves Advantages: Serbia's progressive alignment with EU standards is strengthening rather than undermining its position. The country is harmonizing its regulatory framework in a measured way that maintains approval speed while enhancing data credibility.¹⁶ This means data generated under Serbia's increasingly EU-aligned system will have even greater acceptance by European regulators, while still avoiding the full complexity of immediate MDR compliance.
• Strategic Value Extends Beyond Regulatory Arbitrage: Even as Serbia moves closer to EU standards, it will likely maintain cost advantages, faster recruitment rates, and a favorable business environment for clinical research. The pre-MDR strategy will evolve into a “pre-full-MDR-cost” strategy, where Serbia offers a more affordable and efficient path to generate EU-quality data.¹⁷

Practical Implementation: Maximizing The Serbian Advantage

To successfully execute the pre-MDR strategy in Serbia, companies should consider these implementation factors:

• Optimal Timing Strategy: Companies should plan to initiate Serbian trials within the next three to five years to maximize the regulatory arbitrage window. This timeline allows completion of initial studies and progression to EU trials well before any potential regulatory changes impact the Serbian advantage.
• Strategic Partner Selection: Success requires selecting clinical research organizations (CROs) with proven experience in Serbia's regulatory system and established relationships with ALIMS. The right partners understand how to generate data satisfying current Serbian requirements while anticipating future EU standards.
• Future-Proofing Documentation: Companies should implement documentation practices that exceed current Serbian requirements and align with anticipated EU standards. This forward-thinking approach ensures that data and processes seamlessly transition to full MDR compliance when needed.¹⁸

A Strategic Imperative With Clear Leadership

For medtech startups with ambitions in the European market, the Balkan pre-MDR strategy offers a compelling solution to MDR-related barriers. However, not all non-EU Balkan states are created equal. Serbia's superior regulatory efficiency, market scale, and infrastructure maturity make it the choice over Bosnia and Herzegovina's complexity, Montenegro's limitations, or Albania's regulatory immaturity.

Rather than undermining this strategy, the question of Serbia's EU accession actually reinforces its value. Companies have a substantial window to leverage Serbia's advantages, and the country's progressive alignment with EU standards enhances rather than diminishes the credibility of data generated there. By the time full MDR compliance is required in Serbia, companies will have already achieved their strategic objective: generating compelling human data to support their EU market entry.

As the medtech industry continues to navigate MDR complexities, those who embrace Serbia's unique position — combining current regulatory efficiency with future EU alignment — will be best positioned to bring their innovations to market efficiently and cost-effectively. In the Balkan puzzle, Serbia provides the most straightforward path forward.

References

1. Svempe L, Dusetzina SB, Green JD, et al. Exploring Impediments Imposed by the Medical Device Regulation on Innovation in the European Union: A Systematic Literature Review. PLoS ONE 2024;19(9): e0307841.
2. MedTech Europe. IVDR & MDR Survey Results 2024: Regulatory burden and cost on manufacturers has grown under IVDR and MDR. MedTech Europe Report March 2025.
3. Dzeparoski M. Regulatory Update on eSubmissions in Balkans. Mathews Journal of Pharmaceutical Science 2024;8(3):30-38.
4. Chambers and Partners. Life Sciences 2025 - Serbia. Global Practice Guides April 2025.
5. Legal 500. Serbia: Life Sciences - Regulatory reliance for medicinal products. The Legal 500 Guide January 2025.
6. Stanišić D, Bogdanović N, Ristić S, et al. Clinical trials in Bosnia and Herzegovina. Medicine (Baltimore) 2022;101(26):e29758.
7. RegDesk. Montenegro Law on Medical Devices 2019: an Overview. RegDesk Regulatory Blog July 2025.
8. Dzeparoski M. Regulatory Update on eSubmissions in Balkans. Mathews Journal of Pharmaceutical Science 2024;8(3):30-38.
9. Roshi D, Tresa E, Lafranconi A, et al. Pharmaceutical policies in post-communist Albania: Progress and challenges toward European Union membership. South Eastern European Journal of Public Health 2021; 16:1-13.
10. European Commission. Albania 2024 Report. European Commission Enlargement Package October 2024.
11. Cromos Pharma. Serbia: a Rising Star in Clinical Research. Cromos Pharma Insights January 2025.
12. Legal 500. Serbia: Life Sciences - The Ethics Committee and ALIMS review process. The Legal 500 Guide January 2025.
13. Cromos Pharma. Clinical trials in Serbia: country overview - Demographics and healthcare sector. Cromos Pharma Insights February 2023.
14. Oximio. Clinical Trials Serbia: Gateway to Europe. Oximio Podcast Transcript November 2024.
15. European Commission. Screening report for Serbia, chapter 28 - consumer and health protection. EU Enlargement Documentation December 2018.
16. Orlic P, Graca B. Serbia: The Intersection of Life Sciences and the Legal World. CEE Legal Matters Magazine 2025;12(6):45-48.
17. Sofpromed. The Ultimate Guide to Clinical Trial Costs in 2025 - Southeast Europe and the Balkans. Sofpromed Clinical Research December 2024.
18. bioaccess. 9 Essential Insights on EU Medical Device Regulation for Innovators. bioaccess Blog September 2025.

About The Author:

Julio G. Martinez-Clark is co-founder and CEO of bioaccess, a market access consultancy that works with medical device companies to help them do early-feasibility clinical trials and commercialize their innovations in Latin America. Julio is also the host of the LATAM Medtech Leaders podcast: A weekly conversation with Medtech leaders who have succeeded in Latin America. He has a bachelor's degree in electronics engineering (BSEE) and a master's degree in business administration (MBA).