Agent · helsodata-2025-327-2

EHDS artikel 2: Definitions

Structural tree: the article's own paragraphs, verbatim.

CELEX 32025R0327 · 2026-08-31 · Weight 66 · minimal-risk

OpenOpen reading. No metering is planned for this class.

EHDSOfficial source

Inputs

• in_scopeThe article applies to the situationboolean
• punktParagraph of the articleenum (1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14)

Rule tree

1. If: alla(in_scope = true, punkt = 1)

   Paragraph 1 applies

   1. For the purposes of this Regulation, the following definitions apply:

   Paragraph 1

2. If: alla(in_scope = true, punkt = 2)

   Paragraph 2 applies

   (a)

   Paragraph 2

3. If: alla(in_scope = true, punkt = 3)

   Paragraph 3 applies

   the definitions of ‘personal data’, ‘processing’, ‘pseudonymisation’, ‘controller’, ‘processor’, ‘third party’, ‘consent’, ‘genetic data’, ‘data concerning health’ and ‘international organisation’ laid down in Article 4, points (1), (2), (5), (7), (8), (10), (11), (13), (15) and (26), respectively, of Regulation (EU) 2016/679;

   Paragraph 3

4. If: alla(in_scope = true, punkt = 4)

   Paragraph 4 applies

   (b)

   Paragraph 4

5. If: alla(in_scope = true, punkt = 5)

   Paragraph 5 applies

   the definitions of ‘healthcare’, ‘Member State of affiliation’, ‘Member State of treatment’, ‘health professional’, ‘healthcare provider’, ‘medicinal product’ and ‘prescription’ laid down in Article 3, points (a), (c), (d), (f), (g), (i) and (k), respectively, of Directive 2011/24/EU;

   Paragraph 5

6. If: alla(in_scope = true, punkt = 6)

   Paragraph 6 applies

   (c)

   Paragraph 6

7. If: alla(in_scope = true, punkt = 7)

   Paragraph 7 applies

   the definitions of ‘data’, ‘access’, ‘data altruism’, ‘public sector body’ and ‘secure processing environment’ laid down in Article 2, points (1), (13), (16), (17) and (20), respectively, of Regulation (EU) 2022/868;

   Paragraph 7

8. If: alla(in_scope = true, punkt = 8)

   Paragraph 8 applies

   (d)

   Paragraph 8

9. If: alla(in_scope = true, punkt = 9)

   Paragraph 9 applies

   the definitions of ‘making available on the market’, ‘placing on the market’, ‘market surveillance’, ‘market surveillance authority’, ‘non-compliance’, ‘manufacturer’, ‘importer’, ‘distributor’, ‘economic operator’, ‘corrective action’, ‘recall’ and ‘withdrawal’ laid down in Article 3, points (1), (2), (3), (4), (7), (8), (9), (10), (13), (16), (22) and (23), respectively, of Regulation (EU) 2019/1020;

   Paragraph 9

10. If: alla(in_scope = true, punkt = 10)

    Paragraph 10 applies

    (e)

    Paragraph 10

11. If: alla(in_scope = true, punkt = 11)

    Paragraph 11 applies

    the definitions of ‘medical device’, ‘intended purpose’, ‘instructions for use’, ‘performance’, ‘health institution’ and ‘common specifications’ laid down in Article 2, points (1), (12), (14), (22), (36) and (71), respectively, of Regulation (EU) 2017/745;

    Paragraph 11

12. If: alla(in_scope = true, punkt = 12)

    Paragraph 12 applies

    (f)

    Paragraph 12

13. If: alla(in_scope = true, punkt = 13)

    Paragraph 13 applies

    the definitions of ‘electronic identification’ and ‘electronic identification means’ laid down in Article 3, points (1) and (2), respectively, of Regulation (EU) No 910/2014;

    Paragraph 13

14. If: alla(in_scope = true, punkt = 14)

    Paragraph 14 applies

    (g)

    Paragraph 14

If no rule matches: The article is not stated to apply, or no paragraph is selected. The agent abstains rather than guesses.

The article text as read

1. 11. For the purposes of this Regulation, the following definitions apply:
2. 2(a)
3. 3the definitions of ‘personal data’, ‘processing’, ‘pseudonymisation’, ‘controller’, ‘processor’, ‘third party’, ‘consent’, ‘genetic data’, ‘data concerning health’ and ‘international organisation’ laid down in Article 4, points (1), (2), (5), (7), (8), (10), (11), (13), (15) and (26), respectively, of Regulation (EU) 2016/679;
4. 4(b)
5. 5the definitions of ‘healthcare’, ‘Member State of affiliation’, ‘Member State of treatment’, ‘health professional’, ‘healthcare provider’, ‘medicinal product’ and ‘prescription’ laid down in Article 3, points (a), (c), (d), (f), (g), (i) and (k), respectively, of Directive 2011/24/EU;
6. 6(c)
7. 7the definitions of ‘data’, ‘access’, ‘data altruism’, ‘public sector body’ and ‘secure processing environment’ laid down in Article 2, points (1), (13), (16), (17) and (20), respectively, of Regulation (EU) 2022/868;
8. 8(d)
9. 9the definitions of ‘making available on the market’, ‘placing on the market’, ‘market surveillance’, ‘market surveillance authority’, ‘non-compliance’, ‘manufacturer’, ‘importer’, ‘distributor’, ‘economic operator’, ‘corrective action’, ‘recall’ and ‘withdrawal’ laid down in Article 3, points (1), (2), (3), (4), (7), (8), (9), (10), (13), (16), (22) and (23), respectively, of Regulation (EU) 2019/1020;
10. 10(e)
11. 11the definitions of ‘medical device’, ‘intended purpose’, ‘instructions for use’, ‘performance’, ‘health institution’ and ‘common specifications’ laid down in Article 2, points (1), (12), (14), (22), (36) and (71), respectively, of Regulation (EU) 2017/745;
12. 12(f)
13. 13the definitions of ‘electronic identification’ and ‘electronic identification means’ laid down in Article 3, points (1) and (2), respectively, of Regulation (EU) No 910/2014;
14. 14(g)

No legal advice. Deterministisk regeluppslagning. Ingen juridisk rådgivning, inget efterlevnadsbeslut, ingen bedömning av ett enskilt ärende.

Citation: 32025R0327 art. 2, Definitions. ExploreWorld Legal, https://legal.exploreworldai.com/agent/helsodata-2025-327/artikel-2 (hämtad 2026-08-31, bevis sha256:e9cce269056e98f0, bygge legal-2026-08-25).