Team-NB Publishes Position Paper on Supporting Micro and Small Medical Device Manufacturers

Team-NB has published the position paper "Micro and Small Enterprise Considerations", presenting recommendations to improve the regulatory environment for micro and small medical device manufacturers operating under the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR).

According to the association, the challenges faced by smaller manufacturers extend beyond notified body fees and are linked to broader structural issues within the European regulatory system. The paper proposes several initiatives aimed at improving regulatory efficiency while preserving the independence and sustainability of notified bodies.

Challenges Facing Micro and Small Manufacturers

According to Team-NB, measures focused solely on reducing notified body fees are unlikely to address the underlying challenges experienced by micro and small manufacturers.

The position paper highlights that these organisations frequently operate with limited regulatory, financial and personnel resources, which can affect their ability to prepare technical documentation, generate clinical evidence and navigate conformity assessment procedures efficiently.

Structured Dialogue Throughout Conformity Assessment

One of the main proposals is the introduction of structured dialogue opportunities between notified bodies and micro and small manufacturers throughout the conformity assessment process.

According to Team-NB, structured discussions following formal rounds of questions could improve mutual understanding, reduce unnecessary iterations and help manufacturers better understand regulatory expectations without compromising the impartiality of notified bodies.

The paper also proposes a non-binding pre-submission process, similar in concept to the FDA's Q-Submission programme, allowing manufacturers to receive high-level feedback on proposed testing strategies, study designs and technical approaches before evidence generation begins.

Risk-Based Surveillance Activities

The position paper recommends a more proportionate approach to post-certification surveillance activities.

According to Team-NB, technical documentation reviews should focus on areas presenting genuine regulatory risk, such as:

• Significant design changes;

• Emerging safety signals;

• Substantive updates to technical documentation;

• Changes affecting device safety or performance.

The association states that a more targeted sampling methodology could reduce unnecessary repetition of technical documentation assessments while maintaining appropriate regulatory oversight.

Strengthening Regulatory Capability

Team-NB also proposes the development of EU and Member State-funded programmes to strengthen regulatory capability among micro and small manufacturers.

Suggested initiatives include:

• MDR and IVDR onboarding programmes;

• Educational webinars and training resources;

• Technical documentation readiness reviews;

• Standardised guidance addressing common non-conformities.

According to the paper, improving regulatory knowledge at an early stage could enhance submission quality and reduce avoidable assessment delays.

Additional Recommendations

The position paper also proposes several complementary measures to improve the efficiency of the conformity assessment system, including:

• Greater transparency and consistency in the use of regulatory consultants;

• Increased use of remote and hybrid audits where appropriate;

• Harmonisation of guidance documents and technical documentation templates;

• Better alignment of MDCG guidance with assessment stages and device categories.

According to Team-NB, these measures could improve predictability, submission quality and overall regulatory consistency while reducing unnecessary administrative burden.

Relevance for Medical Device and IVD Manufacturers

The position paper is particularly relevant for micro and small medical device and IVD manufacturers seeking to navigate the MDR and IVDR conformity assessment process more efficiently.

Topics of particular interest include:

• Structured dialogue with Notified Bodies;

• Risk-based surveillance activities;

• Regulatory capability development;

• Technical documentation readiness;

• Remote and hybrid audits;

• Harmonisation of regulatory guidance;

• Support for MDR and IVDR compliance.

According to Team-NB, a more proportionate, predictable and collaborative regulatory framework could improve access to conformity assessment while maintaining high standards of safety, performance and regulatory integrity.