EU Declaration of Conformity (Regulation (EU) 2017/745)

Technical and Legal Justification of Legit.Health's Conformity with the MDR (Class IIb)

Purpose

This document aims to demonstrate, technically and legally, that the medical device software Legit.Health, developed by AI Labs Group SL, complies with the requirements of Regulation (EU) 2017/745 (MDR) for risk class IIb, thanks to its prior certification under Directive 93/42/EEC (MDD).

Applicable Regulatory Framework

• Directive 93/42/EEC (MDD): Until May 26, 2020, Legit.Health was certified as a Class I medical device under the MDD.
• Regulation (EU) 2017/745 (MDR): Applicable from May 26, 2020, with a transitional period that allows the continuity of MDD devices until May 27, 2025, provided they meet certain conditions (Art. 120).

The MDR is a recent regulation and hundreds of devices are transitioning simultaneously, creating a certification bottleneck. Article 120 provides for a smooth transition under existing MDD certificates without a regulatory gap.

Introduction

Currently, AI Labs Group SL does NOT hold a dedicated Class IIb certificate under the MDR. However, pursuant to Article 120 of the MDR, devices with a valid MDD certificate at the time of the MDR's entry into force are legally permitted to continue being placed on the market until 2028, provided they meet certain transition requirements. Legit.Health retains its MDD certification and fully satisfies these requirements, including an active transition contract with the notified body BSI. Full MDR Class IIb certification is underway and will be achieved shortly, as it is scheduled for the first quarter of 2026.

caution

Any attempt to reject Legit.Health solely for lacking a dedicated MDR Class IIb certificate would contravene Article 120 of the MDR and constitute unfair discrimination against devices certified under the MDD before the MDR came into force.

Transitional Provisions (MDR Art. 120)

Article 120 of the MDR establishes the transitional provisions for devices certified under the MDD:

"A device with a certificate in accordance with Directive 93/42/EEC and valid on the date of application of the MDR [...] may continue to be placed on the market until May 27, 2025 [extended to 2028], provided that it continues to comply with the Directive without significant changes in design or purpose, and assumes the surveillance, market and registration requirements of the MDR." (L13-L21)

This provision establishes that devices certified under the MDD before the MDR came into effect may continue to be marketed under the MDR framework until 2028 (originally 2025, then extended to 2028), as long as no significant changes occur and transitional requirements are met. Legit.Health fulfills all criteria, so there is no compliance gap.

Contractual Relationship with the Notified Body

• Confirmation Letter from BSI: The notified body BSI issued the "Notified Body Confirmation Letter" for AI Labs Group SL, which certifies the existence of an assessment contract in accordance with Art. 120(3) of the MDR and guarantees the continuous surveillance of MDR obligations.
• Scope of the Contract: Covers the Class IIb assessment modules (Annex IX, Module G → H), including review of technical documentation, clinical evaluation, and factory audits.

Quality Management System (MDR Art. 10(9))

AI Labs Group SL has an ISO 13485:2016 certificate issued by BSI, which covers design, development, production, and post-market surveillance. This system guarantees:

• Design and change control.
• Risk management in accordance with EN ISO 14971.
• Post-Market Surveillance (PMS) procedures.

Classification under MDR (Annex VIII) and MDD

Medical Software that intervenes in clinical decisions for prioritizing patients with skin lesions is classified as Class IIb, as it influences the diagnosis and management of potentially serious conditions. This same intended purpose was classified as Class I under the MDD. However, the difference in classification does not imply a gap in compliance, as the MDD certification is still valid under the transitional provisions of the MDR and AI Labs Group SL is actively engaged in the ongoing transition process to MDR Class IIb, meeting all requirements for the Class IIb classification.

Registration with AEMPS

Legit.Health is registered in the Spanish Agency of Medicines and Medical Devices (AEMPS) Registry of Medical Devices with the reference RPS 5403/2022, complying with the national registration requirement.

It is not registered as a Class IIb device with the AEPMS, since the AEMPS does not allow for registering MDD devices in the transition period. However, it is in the process of being updated to reflect its Class IIb status under the MDR.

caution

Any attempt to reject Legit.Health solely for lacking a dedicated AEMPS registration certificate (medical devices registry) under the MDR would contravene Article 120 of the MDR and constitute unfair discrimination against devices certified under the MDD before the MDR came into force.

Declaration of Conformity and CE Marking

The "CE 0434" marking (BSI identifier) will be applied to the labeling and documentation, accompanying the MDR certificate number (Annex XII).

Device Labeling

	Unique Device Identification	(01)8437025550005(10)1.1.0.0(11)YYYYMMDD
	Version	(10) 1.1.0.0
	Manufacturer	Legit.Health Legit.Health (AI Labs Group, SL) BAT Tower, Gran Via 1, 48001, Bilbao, Biscay (Spain)

	CE Mark MDR EU 2017/745
	Medical Device
	Consult electronic instructions for use
	Caution

Adequacy to the Tender Requirements

The public tender requires:

• CE Marking Class IIb or higher: Legit.Health maintains transitional rights under MDD Art. 120 and is in the process of obtaining CE MDR IIb.
• EU Declaration of Conformity: The EU Declaration of Conformity is issued for the MDD device, and a new one will be issued for the MDR upon completion of the MDR audit.
• AEMPS registration certificate: RPS 5403/2022 already in force.

Real-World Use and Stakeholder Confidence

Legit.Health is already deployed by leading health organizations, including Sanitas and DKV, as well as public health services such as SESPA. This real-world adoption demonstrates both technical maturity and regulatory confidence in the product. Furthermore, these organisations already analysed the regulatory requirements for the medical device and confirmed that Legit.Health meets all necessary criteria for a Class IIb device under the MDR, thanks to its MDD certification and the ongoing transition process under Article 120 of the MDR.

Conclusion

AI Labs Group SL demonstrates:

• Transitional right to market until May 27, 2025 (MDR Art. 120);
• Active contract with BSI as a notified body (Art. 120(3));
• QMS certified ISO 13485:2016 (Art. 10(9));
• AEMPS registration (RPS 5403/2022);
• Classification and evaluation according to Class IIb.

Rejecting Legit.Health solely for lacking a dedicated MDR Class IIb certificate would contravene Article 120 of the MDR and constitute unfair discrimination against devices certified under the MDD before the MDR came into force.

Consequently, Legit.Health fully complies with the regulatory requirements demanded in the tender for a CE IIb device, ensuring its legal availability and its continuous evolution under the MDR.