Slide background
Slide background




Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746

ID 20476 | | Visite: 3529 | Documenti Marcatura CE UEPermalink: https://www.certifico.com/id/20476

Manual on borderline and classification under Regulations MD

Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746

ID 20476 | 27.09.2023

Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices 

Version 3 - September 2023

Determining whether a given product falls under the definition of a medical device and the application of the classification rules fall within the competence of the authorities of the Member States where the product is on the market. However, when different interpretations of EU legislation occur, public health may be put at risk and the internal market distorted. As both are matters of concern to the Member States and the Commission, it essential to facilitate a dialogue among regulators. Appropriate participation of various stakeholders should also be ensured. This document, hereafter called the Manual, records the agreements reached by the Member State members of the Borderline and Classification Working Group (BCWG) following the exchanges under the Helsinki Procedure under Regulation (EU) 2017/745 on medical devices (the MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR).

The purpose and operation of the Helsinki procedure is described in the dedicated document here. The BCWG is chaired by the European Commission and consists of representatives of competent authorities from all Member States with a number of stakeholder associations as observers. The aspects concerning the borderline between medical devices and other types of products, also known as qualification of a product, are generally governed by Article 4 Regulatory status of products of the MDR and the corresponding Article 3 of the IVDR. Borderline cases are those for which it is not clear from the outset whether a given product is a medical device, or an in vitro diagnostic medical device (IVD), or not.

Various paragraphs under Article 1 Subject matter and scope of both Regulations are also relevant. They exclude certain types of products from the scope of the Regulations. Where a given product does not fall within the definition of medical device or is excluded from their scope, other EU or national legislation may be applicable. This Manual will however not provide indications to that effect.

The Manual should be read in conjunction with other documents providing guidance on borderline, such as MDCG 2022-5 Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices and MDCG 2019-11 Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746

Once a product is qualified as a medical device, a certain risk class will be assigned to it, namely I, IIa, IIb, III. For a product qualified as an IVD, the risk classes are A, B, C and D. The aspects concerning classification of medical devices are governed by MDR Article 51 Classification of devices and Annex VIII Classification rules. For IVDR the corresponding references are Article 47 and Annex VIII. In the context of this Manual, classification cases are those for which the competent authorities of the Member States identify a difficulty in the uniform application of the classification rules. 

The Manual should be read in conjunction with other documents providing guidance on classification, such as MDCG 2021-24 Guidance on classification of medical devices and MDCG 2020-16 Guidance on classification rules for in vitro diagnostic medical devices under Regulation (EU) 2017/746.

This Manual does not relieve national competent authorities from their duty to issue decisions in the areas of qualification and classification for individual products taking into account all its characteristics on a case-by-case basis, while acting under the supervision of the courts.  

Note

Starting from September 2022, a new series of the Manual on borderline and classification was initiated under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices. The previous Manual issued under Directive 93/42/EC on medical devices, Directive 90/385/EEC on active implantable medical devices and Directive 98/79/EC on in vitro diagnostic medical devices will not be updated anymore.

The MDCG Working Group on Borderline and Classification decided to keep the Manual under the Directives available for reference and use as long as devices with CE-marking issued under the Directives remain available on the market.

The latest and last version of the Manual under the Directives: Medical devices | Manual on borderline and classification

Table of contents

Introduction and scope

1. Regulation (EU) 2017/745 on medical devices

1.1. Qualification of medical devices
1.1.1. Borderline between medical devices and IVDs
1.1.2. Borderline between medical devices and medicinal products, including advanced therapy medicinal products (ATMPs)
1.1.3. Borderline between medical devices and biocides
1.1.4. Borderline between medical devices and substances of human origin
1.1.5. Borderline between medical devices and cosmetic products
1.1.6. Borderline between medical devices and food
1.1.7. Borderline between medical devices and personal protective equipment
1.1.8. Borderline between medical devices and general consumer products
1.1.9. Other medical device borderlines
1.2. Classification of medical devices
1.2.1. Rule 1
1.2.2. Rule 2
1.2.3. Rule 3
1.2.4. Rule 4
1.2.5. Rule 5
1.2.6. Rule 6
1.2.7. Rule 7
1.2.8. Rule 8
1.2.9. Rule 9
1.2.10. Rule 10
1.2.11. Rule 11
1.2.12. Rule 12
1.2.13. Rule 13
1.2.14. Rule 14
1.2.15. Rule 15
1.2.16. Rule 16
1.2.17. Rule 17
1.2.18. Rule 18
1.2.19. Rule 19
1.2.20. Rule 20
1.2.21. Rule 21
1.2.22. Rule 22

2. Regulation (EU) 2017/746 on in vitro diagnostic medical devices

2.1 Qualification of IVDs
2.1.1. Borderline between IVDs and medical devices
2.1.2. Borderline between IVDs and general laboratory equipment
2.1.3. Other IVD borderlines
2.2 Classification of IVDs
2.2.1. Rule 1
2.2.2. Rule 2
2.2.3. Rule 3
2.2.4. Rule 4
2.2.5. Rule 5
2.2.6. Rule 6
2.2.7. Rule 7

Index

Fonte: EU

Collegati

Descrizione Livello Dimensione Downloads
Allegato riservato Manual on borderline and classification under Regulations (EU) 2017 745 and 2017 746.pdf
September Ver. 3 2023
248 kB 3

Tags: Marcatura CE Abbonati Marcatura CE Regolamento Dispositivi Medici Regolamento DMD Vitro

Ultimi archiviati Marcatura CE

Ott 29, 2024 76

Decisione (UE) 2024/2779

Decisione (UE) 2024/2779 ID 22821 | 29.10.2024 Decisione (UE) 2024/2779 della Commissione, del 24 ottobre 2024, che istituisce il gruppo di esperti sulla progettazione ecocompatibile dei prodotti sostenibili e sull’etichettatura energetica (forum sulla progettazione ecocompatibile) (GU L 2024/2779… Leggi tutto
Ott 22, 2024 148

Regolamento di esecuzione (UE) 2024/994

Regolamento di esecuzione (UE) 2024/994 / Ecodesign banca dati dei prodotti ID 22773 | 22.10.2024 Regolamento di esecuzione (UE) 2024/994 della Commissione del 2 aprile 2024 recante i dettagli operativi della banca dati dei prodotti istituita a norma del regolamento (UE) 2017/1369 del Parlamento… Leggi tutto
Set 21, 2024 2153

Decreto 17 settembre 2024 n. 133

Decreto 17 settembre 2024 n. 133 ID 22594 | 21.09.2024 Decreto 17 settembre 2024 n. 133 - Regolamento di modifica al decreto 29 luglio 2008, n. 146 concernente il regolamento di attuazione dell'articolo 65 del decreto legislativo 18 luglio 2005, n. 171, recante il codice della nautica da diporto.… Leggi tutto
Decreto 23 luglio n  124
Set 05, 2024 777

Decreto 23 luglio 2024 n. 124

Decreto 23 luglio 2024 n. 124 / Regolamento centri di istruzione per la nautica ID 22512 | 05.09.2024 Decreto 23 luglio 2024 n. 124 Regolamento di disciplina dei centri di istruzione per la nautica ai sensi dell'articolo 49-octies, del decreto legislativo 18 luglio 2005, n. 171. (GU n. 208 del… Leggi tutto

Più letti Marcatura CE

Ott 28, 2024 116593

Regolamento Prodotti da Costruzione (UE) 305/2011 - CPR

Regolamento CPR (UE) 305/2011 Regolamento (UE) N. 305/2011 del Parlamento Europeo e del Consiglio del 9 marzo 2011 che fissa condizioni armonizzate per la commercializzazione dei prodotti da costruzione e che abroga la direttiva 89/106/CEE del Consiglio (Testo rilevante ai fini del SEE) (GU L 88/10… Leggi tutto