New Ordinance that establishes the duties of owners of radiological equipment in dentistry and veterinary medicine
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SubscribeDecree-Law no. 108/2018, which establishes the legal regime for radiological protection, determines in its article 24 that the duties of the owners of intraoral radiography equipment in dentistry and equivalent sources in the field of veterinary medicine are regulated by a specific ordinance.
This rule was introduced during the 2024 revision of the legal regime for radiological protection, in which it was clarified that the use of radiological equipment in the field of dentistry and veterinary medicine would be subject to registration and, consequently, it was intended to specify the obligations to which the holders of this equipment/practices would be subject.
Thus, after almost two years, Ordinance No. 435/2025/1, of 11 December, was published, which establishes the duties of the owners of intraoral radiography equipment in dentistry and equivalent sources in the field of veterinary medicine.
The duties arising from Ordinance No. 435/2025/1 are already known to both the owners of equipment in the dental and veterinary medicine sectors, insofar as they already result, for the most part, from the provisions of Decree-Law No. 108/2018, as outlined below:
Dentistry (Article 3 of the Ordinance)
| Obligation | Ordinance Rule | DL 108/2018 Rule |
| Application for registration of practice and five-year renewal | Article 3(a) | Article 22(2)(a); Article 35(5) and (6) |
| Maintenance of an optimal level of protection through quality assurance tests | Article 3(b) | Article 24(1)(a) |
| Maintenance tests to the manufacturer's specifications | Article 3(c) | New |
| New tests in case of equipment changes or replacement | Article 3(d) | New |
| Responsibility for the safety and security of sources and documented internal organization | Article 3(e) | Article 24(1)(b) |
| Preparation and periodic review of radiological safety assessments | Article 3(f) | Article 24(1)(c) |
| Maintenance and periodic verification of radiation sources | Article 3(g) | Article 24(1)(g) |
| Information for workers on radiation risks | Article 3(h) | Article 64(1)(a) (a) and (b) |
| Protection of external workers | Article 3(i) | Article 90 |
| Written protocols for medical radiological procedures | Article 3, al. j) | Article 102(3) |
| Close surveillance of medical radiological equipment | Article 3(k) | Article 104(1) |
| Raising awareness among pregnant and breastfeeding women | Article 3, al. l) | Article 106(4) |
| Consultation of radiological protection specialists | Article 3(m) | Article 24(1)(k) |
Veterinary Medicine (Article 4 of the Ordinance)
| Obligation | Ordinance Rule | DL 108/2018 Rule |
| Maintenance of an optimal level of protection for workers, the public and the environment | Article 4(a) | Article 24(1)(a) |
| Responsibility for the safety and security of sources and documented internal organization | Article 4(b) | Article 24(1)(b) |
| Periodic review of radiological safety conditions | Article 4(c) | Article 24(1)(c) |
| Management system with safety and security procedures | Article 4(d) | Article 24(1)(d) |
| Procedures for recording and reporting incidents/accidents to APA | Article 4(e) | Article 24(1)(e) |
| Measures to reduce the consequences of incidents/accidents | Article 4(f) | Article 24(1)(f) |
| Maintenance and periodic verification of radiation sources | Article 4(g) | Article 24(1)(g) |
| Public exposure measurement and evaluation equipment | Article 4(h) | Article 24(1)(i) |
| Metrological verification and control of measuring instruments | Article 4(i) | Article 24(1)(j) |
| Consultation of radiological protection specialists | Article 4, al. j) | Article 24(1)(k) |
Thus, what the Ordinance offers is a systematization and condensation of the duties of these operators in dedicated articles, providing greater clarity and legal certainty to operators in these sectors. It is therefore recommended that professionals in these areas review their internal procedures to ensure full compliance with the now consolidated regulatory framework.
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