HEALTH INNOVATION

Technology-Based Medical Devices – Notified Body in Portugal

(MDS ON-PT Project)

The MDS ON-PT project aims to establish a Notified Body (NB) in Portugal for the conformity assessment of technology-based medical devices that incorporate or are controlled by software, sensors, or integrated electronics.

The project results from a partnership between the University of Aveiro, the University of Beira Interior, the University of Coimbra, Inova-Ria, and the PDTH Association, and is co-financed by European funds under the Centro 2030 Programme.

Goals

MDS ON-PT structures its activities around a set of strategic objectives aimed at strengthening Portugal’s national medical device conformity assessment ecosystem.

01
Establishment of the Notified Body

To establish the first Portuguese Notified Body for the conformity assessment of technology-based medical devices, in alignment with MDR and IVDR regulations.

02
Support for Start-ups and SMEs

To facilitate access to regulated markets for innovative companies by reducing certification barriers and accelerating the entry of health solutions into the European market.

03
Reduction of External Dependency

To reduce reliance on foreign notified bodies, thereby strengthening national sovereignty in the field of medical technology certification.

04
Ecosystem Coordination

To promote collaboration among industry, universities, research centres, and healthcare providers, fostering synergies that create added value.

05
Strengthening Strategic Sectors

To support the development of sectors such as electronics, microelectronics, moulds, plastics, and advanced materials, thereby strengthening the medical device value chain in Portugal.

06
International Reach

To position Portugal as a key player in the certification and development of health technologies, strengthening the Centro Region’s role in this field and extending its impact nationally and across Europe.

Promoting Entity

(Lead Beneficiary)

Institutional Partners

TOTAL INVESTMENT

€ 2,940,998.28

FINANCIAL SUPPORT FROM THE EUROPEAN UNION

€ 2,131,725.01

PROJECT CODE

CENTRO2030-FEDER-02195100

PROJECT DURATION

36 Months

Download the Project Form

Implementation Roadmap

Development phases of the MDS ON-PT project leading up to its launch.

Phase 1
Diagnosis

Ecosystem analysis and benchmarking.

Phase 2
Management System

Implementation of a management system for the NB.

Phase 3
Training and Experts

Training of HR personnel and establishment of a pool of experts.

Phase 4
Setup and Accreditation

Development of the infrastructure and preparation for accreditation.

Phase 5
Ecosystem and Partnerships

Strengthening the national healthcare ecosystem.

Co-funded by:

Centro 2030
Portugal 2030
European Union