SBA Response and comments to the updated proposals for the PPWR issued by the European Commission. Version – December 2023.

Guidance on moving from MDD to MDR

SBA Response and comments to the updated proposals for the PPWR issued by the European Commission.

SBA Response and comments to the updated proposals for the PPWR issued by the European Commission November 2022.

Following recent requests for guidance on how to apply the new SBS symbols, this image shows a double SBS with an outer PP, and shows the recommended configuration for each layer.

Following a series of webinars presenting the initial assessment by Eunomia of the project they are perfroming for the European Commission in the support of the Packaging and Packaging Waste Directive, the SBA prepared a feedback document, which attempted to highlight the regulatory and patient safety concerns that the proposals presented.

The document was sent to Eunomia on 8th July 2021.

The Sterile Barrier Association (SBA) created and validated new symbols to inform users about the configuration of Sterile Barrier Systems (SBS) respective packaging systems for sterile medical devices. The objective is to assist healthcare users with performing appropriate aseptic technique.

The purpose of this document is to answer the most common questions related to applying the symbols and using packaging which includes these symbols.

Sterile Barrier Association (SBA) ha creado y validado nuevos símbolos, para informar a los usuarios sobre la configuración de los Sistemas de Barreras Estéril (SBE) en los respectivos sistemas de embalaje de los dispositivos médicos estériles. El objetivo es ayudar a los usuarios sanitarios para que lleven a cabo una apropiada técnica aséptica.

El propósito de este documento es responder las preguntas más comunes relacionadas con la aplicación de los símbolos y el uso de los embalajes que incluyen estos símbolos.

The Sterile Barrier Association (SBA) created and validated new symbols for Sterile Barrier System (SBS) configurations respective packaging systems for sterile medical devices for inclusion into ISO 15223-1. – 08/2019

Revised 09/2020 to included position of the Symbol

Sterile Barrier Associaton (SBA) ha creado y validado nuevos símbolos para los sistemas de barrera estéril (SBE), en lo que se refiere a configuración de sistemas de embalajes para dispositivos médicos, para incluirlos en la ISO15223-1.

滅菌バリア協会(SBA)はISO 15223-1に加えるために、滅菌医療機器の包装システムに関する無菌バリアシステム（SBS）の新しいシンボルを作成し、バリデーションしました。

Guidance-Doc-SYMBOLS-201908-1v5.2_Japanese

Common Specifications (CS) on the reprocessing and further re-use of single-use medical devices within a health institution, as foreseen in Articles 17(3) and 17(5) of the Medical Devices Regulation (MDR)

Please note (ref: MedTech Europe – MTE)

• These CS do not regulate cases where a manufacturer reprocesses another manufacturer’s single-use device for further circulation on the EU market.
• These CS will regulate cases where

1. the national law of a given EU Member State permits the reprocessing and further re-use of single-use devices in their own national territory, and where
2. that Member State decides to allow health institutions to reprocess single-use devices for their own, in-house, re-use, without complying with all ‘manufacturer’ obligations

The Act is available online in all EU languages, here: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2020.273.01.0003.01.ENG&toc=OJ:L:2020:273:TOC

Results from the SBA validation study on proposals for new Sterile Barrier System (SBS) symbols for the MDR. – 04/2018

European Union guidance notes for manufacturers of class 1 medical devices. – 06/2009

SBA review of current relevant legislation and standards affecting Sterile Barrier Systems for the European Medical Device Market – 06/2015

SBA guidance, use of sterile barrier systems for medical devices to maintain sterility and help prevent Healthcare Associated Infections (HAI’s). – 09/2015

SBA position paper on the Packaging and Packaging Waste Directive (94/62/EC) 1994 amended by Directive 2004/12/EC – Essential Requirements. – 04/2012

SBA guidance in the procedures necessary to ensure consistency in results for the EN 868-5 Seal Strength Test. – 02/2015

SBA Guidance Document on the CE marking of Sterile Barrier Systems. – 06/2015

MedTech Europe (MTE) policy paper on the implemention of the new MD and IVD regulations. – 07/2018

MedTech Europe (MTE) flowchart detailing the route to achieve MDR compliance. – 12/2017

Official Journal of the EU for Regulation (EU) 2017/745  & 2017/746  on medical devices and in vitro diagnostic medical devices. – 05/2017

SBA position paper summarising and analysing the key changes in moving from the MDD to the MDR for Sterile Packaging. – 08/2017

SBA – Documento informativo que resume y analiza los cambios clave en la transición del MDD al MDR para los Embalajes Estériles – 08/2017

SBA review of current relevant legislation and standards affecting Sterile Barrier Systems for the European Medical Device Market. – 06/2015

SBA guidance document on the compatibility of materials used for Sterile Barrier Systems with sterilisation processes. – 08/2017

The SBA commissioned independent tests to validate a range of test methods found in the annexes of EN 868 standards to determine their suitability for acceptance into ISO 11607.

Final published paper detailing the SBA commissioned, independent tests, to validate a range of test methods found in the annexes of EN 868 standards to determine their suitability for acceptance into ISO 11607.

EN 868 test method validations consultancy report describing the methodology to be employed in order to complete the SBA commissioned, independent test report, to validate a range of test methods found in the annexes of EN 868 standards and determine their suitability for acceptance into ISO 11607.

User understanding of the new SBS symbols to comply with the General Safety and Performance Requirements (GSPR) of the MDR. – 10/2019