MDCG 2023-6：附件XVI产品等同性证明指南
文件编号：MDCG 2023-6
发布日期：2023年6月
适用法规：EU MDR 2017/745
官方PDF：下载
文件目的
本指南为附件XVI产品（无医疗目的但与医疗器械相似的产品）的等同性证明提供实践指导，帮助制造商和公告机构评估附件XVI产品的安全性。
附件XVI产品概述
EU MDR附件XVI列出了以下无医疗目的但须受MDR监管的产品类别：
| 产品类别 | 示例 |
|---|---|
| 接触镜 | 美容隐形眼镜（无屈光度） |
| 面部填充物 | 透明质酸填充物（美容用途） |
| 皮肤增白产品 | 含化学物质的皮肤增白设备 |
| 非治疗性激光/光设备 | 美容激光脱毛设备 |
| 颅内电刺激设备 | 非治疗性神经刺激设备 |
| 植入物（美容） | 乳房植入物（美容用途） |
| 吸脂设备 | 美容吸脂设备 |
等同性证明的特殊性
附件XVI产品的等同性证明与普通医疗器械不同：
参考器械的选择
附件XVI产品须证明与已上市的医疗器械等同（而非与其他附件XVI产品等同）：
- 参考器械须已获CE标志
- 参考器械须用于类似的解剖部位
- 参考器械须具有类似的技术特征
安全性证明的重点
由于附件XVI产品无医疗收益，安全性评估须特别严格：
- 须证明风险最小化
- 须证明残余风险可接受（即使无医疗收益）
- 须特别关注长期安全性
与 MDCG 2023-5 的关系
- MDCG 2023-5：附件XVI产品的资质认定和分类
- MDCG 2023-6（本文件）：附件XVI产品的等同性证明
相关文件
官方文件全文
MDCG 2023-6
Guidance on demonstration of equivalence for Annex XVI products
A guide for manufacturers and notified bodies
December 2023
This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission.
The document is not a European Commission document and it cannot be regarded as reflecting the official position of the European Commission. Any views expressed in this document are not legally binding and only the Court of Justice of the European Union can give binding interpretations of Union law.
1 Introduction
The Regulation (EU) 2017/745 on medical devices 1 , hereafter referred to as the MDR (medical device regulation), provides a possibility to use clinical data related to an equivalent device in the clinical evaluation required for a device under conformity assessment 2 .
Whilst carrying out a clinical investigation is the most direct way to generate clinical data concerning the safety and performance of devices for the purpose of CE marking, clinical data can also be sourced from data of a device for which the equivalence to the device in question can be demonstrated 3 . In such cases, equivalence shall be demonstrated according to the MDR requirements 4 .
According to Commission Implementing Regulation (EU) 2022/2346 laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 on medical devices 5 , hereinafter referred to as CS, in general it is not possible to demonstrate equivalence between a medical device and a product without an intended medical purpose where all available results of clinical investigations relate to medical devices only. Therefore, clinical investigations should be performed for products without an intended medical purpose 6 .
The guidance document MDCG 20205 on 'Clinical Evaluation Equivalence' 7 also covers the products without an intended medical purpose listed in the Annex XVI of MDR 8 . It was issued in April 2020, before the availability of the CS and with the purposes of highlighting the differences between the MDR and the MEDDEV 2.7/1 rev.4 9 .
2 Scope
This MDCG guidance covers the demonstration of equivalence, based on data pertaining to an already existing device, for the purpose of CE-marking under the MDR and is applicable to products without an intended medical purpose listed in the Annex XVI of MDR and covered by the CS. For dual-purpose devices, which are devices with a medical and a non-medical intended purpose, this guidance applies only to the non-medical intended purpose.
This guidance document should be used in conjunction with MDCG 2020-5 on equivalence.
3 Demonstration of equivalence
3.1 Product without an intended medical purpose vs product without an intended medical purpose
When referring to clinical data from an equivalent device, manufacturers should consider that equivalence between two devices without an intended medical purpose should be demonstrated in accordance with the criteria established in the MDR 10 . In particular, the demonstration has to consider technical, biological and clinical characteristics.
The technical and biological criteria listed in the MDR can be directly considered to compare characteristics of products without an intended medical purpose. The criterion for the clinical characteristics should be considered taking into account that some of them are specifically referring to a medical purpose. The following table clarifies how the characteristics should be considered for products without an intended medical purpose.
| Elements of the Clinical criterion (MDR, Annex XIV Part A Section 3) | Clarifications for the application of the Clinical criterion to products without a medical purpose |
|---|---|
| the device is used for the same clinical condition or purpose , | only 'use d for the same purpose' applies |
| including similar severity and stage of disease , | 'similar severity and stage of disease' is not applicable |
| at the same site in the body, | 'at the same site in the body' is directly applicable |
| in a similar population, including as regards age, anatomy and physiology; | 'in a similar population' is directly applicable as well as the similar 'age', ' anatomy ' and 'physiology' |
| has the same kind of user; | 'the same kind of user' is directly applicable |
| has similar relevant critical performance | 'similar relevant critical performance' is directly applicable |
| in view of the expected clinical effect for a specific intended purpose | the expected 'clinical' effect is not applicable. Nevertheless, the products have expected effects for the specific intended purpose, therefore the requirement should be considered as 'in view of the expected effect for a specific intended purpose' |
3.2 Product without an intended medical purpose vs analogous medical device
In general, a comparison is not possible between a medical device and a product without an intended medical purpose 11 because not all the clinical characteristics can be compared. In particular, the characteristic 'similar severity and stage of disease' would be defined and available for the medical device while it would not be defined and available for the product without an intended medical purpose 12 . As a consequence, the demonstration of equivalence cannot be completed and established between a device without an intended medical purpose and an analogous device with a medical purpose 13 .
3.3 Product without an intended medical purpose vs dual-purpose device
Equivalence between a product without an intended medical purpose and a device with both a medical and a non-medical purpose (dual-purpose device) can be demonstrated comparing the characteristics related to the non-medical purpose for both the devices. For the dual-purpose device, only the characteristics related to the non-medical purpose should be considered.
If equivalence is demonstrated, only clinical data of the dual-purpose device related to the general safety and performance requirements 14 applicable for the non-medical purpose should be used for the clinical evaluation of the product without an intended medical purpose.
MDR, Annex I.
Footnotes
- Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices
- MDR, Article 61 and Annex XIV Part A.
- MDR, Article 2 (48) 2nd and 3rd indent.
- MDR, Annex XIV, Part A (3).
- Commission Implementing Regulation (EU) 2022/2346 laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices -
- CS, recital (11).
- MDCG 20205 'Clinical Evaluation Equivalence', point s (a) and (f) of paragraph 4 on 'Demonstration of equivalence'.
- MEDDEV 2.7/1 rev.4 'Clinical evaluation: Guide for manufacturers and notified bodies' in support of the application of Council Directives 93/42/EEC and 90/385/EEC on medical devices and active implantable medical devices, which have been repealed by the MDR.
- MDR, Annex XIV Part A (3).
- CS, recital (11).
- This further explains the sentence ' To duly justify reliance on existing clinical data from an analogous medical device, the principles of demonstration of equivalence should be applied with the acceptance that the device under evaluation will only have an aesthetic or another non-medical purpose whereas the analogous device has a medical purpose ' from point 4(f) of MDCG 2020 -5.
- In cases where equivalence cannot be demonstrated, data from similar devices may be useful for a variety of other purposes (e.g., ensuring that the risk management system is comprehensive; understanding the state of the art; helping to define the scope of the clinical evaluation) that are listed in point 5 of MDCG 2020-5. 14