DSVG 04 on Breast implants

MDCG 2024-1-4

Guidance on the vigilance system for CE-marked devices

DSVG 04 Breast Implants

January 2024

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.

Contents

1. 1. Introduction ................................ ................................ ................................ ................. 3
2. 2. What should be reported ................................ ................................ ............................. 3

• • Individual serious incident ................................ ................................ ................... 3
• • Periodic Summary Reporting ................................ ................................ ............... 3
• • Trend Reporting ................................ ................................ ................................ .. 4

1. 3. DSVG 04 examples ................................ ................................ ................................ ..... 4
2. 4. Clinical Reference and Clinical Guidelines ................................ ................................ .. 7
3. 5. IMDRF Terminologies for Categorised Adverse Event Reporting ................................ 7
4. 6. References ................................ ................................ ................................ ................. 7

1. Introduction

The aim of this Device Specific Vigilance Guidance (DSVG) is to harmonise vigilance reporting and provide guidance for manufacturers of Breast Implants. It provides further clarification for vigilance reporting of Breast Implants to the relevant Competent Authority and should be read in conjunction with the requirements of Regulation (EU) 2017/745 on medical devices (MDR) [1]. This DSVG does not replace or extend any of those requirements. This document outlines the way to report incidents and serious incidents, defined in Article 2(64) and (65) MDR, in accordance with Articles 87 and 88 MDR, which occurred with Breast Implants to the relevant Competent Authority.

2. What should be reported

It is the manufacturer’s responsibility to judge each event on its own merit and to ensure compliance with the statutory reporting requirements contained within the MDR [1].

• • Individual serious incident

In accordance with Article 87 MDR [1] manufacturers shall report serious incidents to the relevant Competent Authority. Serious incidents are defined in Article 2(65) MDR.

This includes circumstances where the manufacturer is uncertain whether the incident that occurred with a specific device is reportable or need time to obtain clarification about the root cause of the incident, in accordance with Article 87(6) and (7) MDR.

The notification to the relevant Competent Authority should be reported within the timeframes referred to in Article 87(2) and (5) MDR.

For further information and clarification on what constitutes a serious incident and for details on how to apply the reporting timelines of the MDR, please refer to MDCG 2023-31 “Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices” [2].

• • Periodic Summary Reporting

A “Periodic Summary Report” (PSR) is an alternative reporting regime by which the manufacturer, in agreement with the respective national Competent Authority that is coordinating the periodic summary reporting (and in consultation with the Competent Authorities referred to in Article 92(8)(a) MDR, can report similar serious incidents with the same device or device type in a consolidated way.

This is possible when similar serious incidents involving the same specific device or device type occur and for which the root cause has been identified or a field safety

1 MDCG 2023-3 guidance is under revision to include IVDR aspects. Please refer to the updated version when available at the following link: https://health.ec.europa.eu/medical-devices-sector/new-regulations_en#guidance.

corrective action has been implemented or where the serious incidents are common and well documented, as defined in Article 87(9) MDR.

The format, content and frequency of periodic summary reports should be agreed with the Coordinating Competent Authority (in consultation with the Competent Authorities participating in the Periodic Summary Reporting) (Article 87(9) MDR).

Until EUDAMED becomes fully functional, Competent Authorities, economic operators and other relevant parties should follow MDCG 2021-1 Rev. 1 “Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional” [3] (as required under the MDR).

• • Trend Reporting

The requirements for trend reporting are outlined in Article 88 MDR [1].

In accordance with the MDR, the manufacturer should report to a Competent Authority any statistically significant increase in the frequency or severity of incidents that are not serious incidents or that are expected undesirable side-effects that could have a significant impact on the benefit-risk analysis and which have led or may lead to risks to the health or safety of patients, users or other persons that are unacceptable when weighed against the intended benefits. Trends should be identified by the manufacturer as they can be indicative of a change in the risk-benefit ratio.

For further information and clarification on what constitutes incidents and undesirable side-effects please refer to MDCG 2023-3 “Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices” [2].

3. DSVG 04 examples

The following table details Breast Implants examples indicating what should be reported as device-related problems that caused or contributed to the incidents or serious incidents.

The list is for illustrative purposes only and does not constitute an exhaustive list:

Guidance for manufacturers on reporting device-specific serious incidents and incidents under the European vigilance system

To be read in conjunction with the MDR

Title: Breast Implants

* The IMDRF Annexes code associated with each text description are included as guides (please see the Section 5). Report as individual serious incidents Serious incident: Art. 2(65) and Art. 87 MDR Reporting timelines: by 15, 10 or 2 days from the Manufacturer’s awareness in accordance with Art. 87(3) to

1. (5) of the MDR Report at the time the trend is identified

Incidents (Art. 2(64) and Art. 88 MDR) and expected undesirable side-effects*** Can be included in Periodic Summary Reports (PSRs)**

Clinical/symptomatic (IMDRF Annex E codes*)

• • Breast cancer E180101 / E1403
• • Suspected and confirmed cases of BIA-ALCL E180102
• • Lymphoma E180104
• • Double capsule E2341
• • Siliconoma E2317
• • Recurrent seroma/fluid collections E0307
• • Unexpected breast swelling (seroma / fluid collections with no clinical history for trauma or infections) E0307
• • Unexpected breast inflammatory reaction (Breast inflammatory reaction and/or lymphadenopathy with no clinical history for trauma or infections) E0308
• • Unexpected breast infection (Breast Infections with no clinical history for previous systemic infections) E1906
• • Systemic adverse reaction, Hypersensitivity, allergic reaction E0402
• • Autoimmune disease or Syndrome Induced by Adjuvants (ASIA) E0401

Device (IMDRF ANNEX A codes*)

• • Silicone migration A010402
• • Valve failure (during or after implantation) A041001 / A05 / A1501 / A1406

Periodicity

3 Months

3 Months

X Months to be agreed with the CA

Clinical/symptomatic (IMDRF Annex E codes*)

• • Capsular contracture causing breast deformity and/or pain and/or hard breast for implants in place less than 10 years E2303 / E1402 / E2332 / E2308

Device (IMDRF ANNEX A codes*)

• • Implant ruptures for implants in place less than 10 years A0412 / A040101/ A0413 / A0414 / A140102
• • Post FSCA/FSN incidents**** Clinical / Symptomatic (IMDRF Annex E codes*)
• • Capsular contracture causing breast deformity and/or pain and/or hard breast for implants in place more than 10 years E2303 / E1402 / E2332 / E2308
• • Wrinkling of the breast E1723
• • Loss of nipple sensitivity E1409
• • Breast swelling/ infection/ inflammatory reaction and/or Lymphadenopathy with positive clinical history for previous systemic infections or trauma E2338
• • Calcium deposits E230901

Device (IMDRF Annex A codes*)

• • Implant ruptures for implants in place more than 10 years A0412 / A040101 / A0413 / A0414 / A140102
• • Rotation /folding/ displacement of the implant A010402 / A0512
• • Extrusion of the implant A0411 / A050401

** If you can’t use PSR, then report these serious incidents individually, using MIR Form. The format, content and frequency of PSRs should be arranged with the Coordinating Competent Authority. *** Any statistically significant increase in the frequency or severity of incidents, expected undesirable side-effects shall be reported by the manufacturer in accordance with Article 88(1) MDR. **** Serious incidents that occur after implementation of an FSCA provided they have been previously agreed with Competent Authority.

4. Clinical Reference and Clinical Guidelines

Clinical references or current clinical guidelines for Breast Implants may be used by manufacturers in order to identify incident examples and complications.

Breast Implants manufacturers may refer to relevant local clinical guidelines when identifying incident examples and complications.

5. IMDRF Terminologies for Categorised Adverse Event Reporting

The text descriptions of Medical device problems (IMDRF Annex A) and Health effects-Clinical signs and symptoms (IMDRF Annex E) in the table are examples of what should be reported and refer to the IMDRF Annex A and E release No. 2023.

Please note that manufacturers should consult the most recent version of the IMDRF adverse event code.

The following link is provided to facilitate consultation: https://www.imdrf.org/documents/terminologies-categorized-adverse-event- reporting-aer-terms-terminology-and-codes.

6. References

[1] Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. [2] MDCG 2023-3 “Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices ”. Link: https://health.ec.europa.eu/system/files/2023-02/mdcg_2023-3_en_0.pdf. [3] MDCG 2021-1 Rev. 1 “ Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional ”. Link: https://health.ec.europa.eu/system/files/2021-05/2021-1_guidance- administrative-practices_en_0.pdf.