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SGS rounds up the latest updates on the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulations (IVDR).

EU Commission Updates Medical Devices Portal

In March, as part of the EU Commission’s mission to provide a more unified web presence, the Medical Devices webpages were significantly restructured and updated to provide a more comprehensive information section, structured around user needs. The main Medical Devices portal provides the latest highlights, and new guidance including factsheets for:

  • Manufacturers of medical devices – covering key changes
  • Manufacturers of IVD medical devices – covering the critical changes and new obligations for manufacturers
  • Procurers – aimed at people within hospitals, clinics, and other organizations responsible for the procurement of medical devices and IVDs, looking at changes and potential impacts on their purchasing organizations
  • Authorized representatives, importers and distributors of medical devices and IVDs – aimed at these regulatory roles, with key impacts of the regulations on their responsibilities and some FAQs

We have linked and highlighted these updates and factsheets on the SGS Medical Devices website.

A further enhanced webpage is available called the Regulatory Framework. This offers useful guidance documents on Regulations MDR (EU) 2017/745 and IVDR (EU) 2017/746, which includes:

  • Download links for the new regulations from the EU Official Journal
  • The New Regulations in a Nutshell – a summary of the regulatory intent and key changes, and also the main reasons behind this change
  • Getting Ready for the New Regulations – an infographic that illustrates the key information and resources for medical device IVD manufacturers and other roles, such as authorized representatives, importers and distributors
  • Medical Device Coordination Group – useful details on the purpose and remit of this new group defined by the regulations
  • Guidance documents – links to current directive guidance, factsheets and other information, including:
    • Implementation of Medical Devices EU-Regulation – focus on manufacturers’ obligations
    • Implementation model for MDR – a step-by-step guide on what an MD manufacturer needs to know and do 
    • Implementation model for IVDR – a step-by-step guide on what an IVD manufacturer needs to know and do

MDR and IVDR Corrigendum Published in May 2019

The expected Corrigendum documents to formally update and make minor corrections to the regulations have been drafted by the EU Commission. As of March 13, 2019, these have been provided to all the member states for their review and comment.

The intention, apart from correcting typographical errors, is to clarify some points of divergent opinion or interpretation that have been identified during the designation process for Notified Bodies.

These Corrigendum documents have been published in the EU’s Official Journal on the May 5, 2019.

Updates to Standards

A number of standards have been updated, as listed below.

EN ISO 11737-1:2018 Sterilization of health care products – Microbiological methods: Part 1: Determination of a population of microorganisms on products

This has been published as the third edition, replacing the previous version of 2006 and incorporating the Technical Corrigendum issued in 2007. This version has however not yet been harmonised by the EU Commission.

EN ISO 11737-2 Sterilization of health care products – Microbiological methods: Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

This draft will be the third edition, anticipated for publication in 2019 which will replace the 2009 edition and is currently in the final stages of balloting. Again, this will then need to be harmonised by the EU.

ISO 10993-1: 2018 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process

Updated and published by ISO, but not yet harmonised by the EU.

ISO 14155: Role of Risk Management in Clinical Investigations

A new third edition of the standard is expected for publication in 2019. It is expected to align more closely with ISO 14971 requirements.

SGS Updates Website

To ensure compliance with regulations, SGS has reworked its website to provide a clearer structure and more information on our CE marking service.

SGS has also developed specialized training to help you to transition to MDR and IVDR:

For more information, please contact:

Virginie Siloret
Global Product Manager - Medical Devices Regulation
t: +41 22 739 98 58

Sharon Williams
Global Product Manager - IVDR
t: +44 (0) 19 345 22 917