Harmonized Standards for Medical Devices
In July 2021, the European Commission published an Implementing Decision on the harmonized standards for medical devices. These standards were drafted in support of Regulation (EU) 2017/745, the new EU Medical Devices Regulation.

HARMONIZED STANDARDS TO SUPPORT THE EUROPEAN UNION MEDICAL DEVICES REGULATION         

The European Union (EU) has a competitive and innovative medical devices sector with over 500 000 types of medical devices and in vitro medical devices placed on its market. The EU Medical Devices Regulation (MDR – Regulation (EU) 2017/745) lays down the rules regarding the placing on the market, making available on the market or putting into service of medical devices for human use (and accessories for such devices). The Regulation (EU) 2017/746 sets out the rules on in vitro diagnostic medical devices (IVDR), as explained in our previous post.

The MDR has entered in force on May 26 this year and on July 16th the European Commission published harmonized standards for medical devices (Commission Implementing Decision (EU) 2021/1182), to support the MDR. This Implementing Decision entered in force at the same date of its publication.

The European Committee for Standardization (CEN) revised the existing harmonized standards (EN ISO 11135:2014, EN ISO 11137-1:2015, EN ISO 11737-2:2009 and EN ISO 25424:2011) and included the latest technical and scientific progress, adapting them to the relevant requirements of the MDR. This resulted in the adoption of new harmonized standards EN ISO 11737-2:2020 and EN ISO25424:2019 and of the amendments EN ISO 11135:2014/A1:2019 to EN ISO 11135:2014 and EN ISO 11137-1:2015/A2:2019 to EN ISO 11137-1:2015. CEN drafted the new harmonized standard: EN ISO 10993-23:2021.

Together with CEN, the Commission assessed and concluded that the standards revised and drafted comply with the requirements set out in the MDR. Consequently, the references of those standards were published in the Official Journal of the European Union – Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 on harmonized standards for medical devices drafted in support of Regulation (EU) 2017/745 of the European Parliament and of the Council – as followed:

  1. EN ISO 10993-23:2021 – Biological evaluation of medical devices – Part 23: Tests for irritation (ISO 10993-23:2021);
  2. EN ISO 11135:2014 – Sterilization of health care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014) – EN ISO 11135:2014/A1:2019;
  3. EN ISO 11137-1:2015 – Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013) – EN ISO 11137-1:2015/A2:2019;
  4. EN ISO 11737-2:2020 – Sterilization of health care products – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019);
  5. EN ISO 25424:2019 – Sterilization of health care products – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018).

If you wish to get more information on the EU-MDR, do not hesitate to contact us at info@criticalcatalyst.com.

References:

  1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02017R0745-20200424&from=EN
  2. Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 on harmonized standards for medical devices drafted in support of Regulation (EU) 2017/745 of the European Parliament and of the Council. Available at: https://eur-lex.europa.eu/eli/dec_impl/2021/1182/oj

further
reading

cosmetic products

New Amendments to the European Cosmetics Regulation – CMR Substances

The European Commission published the Commission Regulation (EU) 2022/1531, which amends Regulation (EC) No 1223/2009 in regards to the use in cosmetic products of certain substances classified as CMR. This amendment introduces new entries to Annex II and Annex III and revises an entry to Annex V to Regulation (EC) No 1223/2009.

Read More »
medical devices

EUDAMED – harmonized practices and alternative solutions for IVDR until the database is fully functional

EUDAMED is one of the key aspects of the new rules on in vitro diagnostic medical devices – Regulation (EU) 2017/746. However, it is only expected to achieve full functionality by the second quarter of 2024. Until then, how is the information submitted and/or exchanged between manufacturers, notified bodies and competent authorities?

Read More »
medical devices

EUDAMED – update on timelines

EUDAMED is one of the key aspects of the new rules on medical devices (Regulation (EU) 2017/745) and in vitro diagnostic medical devices (Regulation (EU) 2017/746), and it is expected to achieve full functionality by the second quarter of 2024.

Read More »
cosmetic products

UK OPSS call for data on six cosmetic ingredients

On 14 July 2022, the Office for Product Safety and Standards (OPSS – the UK regulator for cosmetic products) issued a call for data on the safety of the following six cosmetic ingredients to investigate any suspected endocrine disrupting properties. 

Read More »
cosmetic products

European Commission Recommendation on the Definition of Nanomaterial

Nanomaterials are increasingly used in cosmetics and personal care products. They are similar to other chemicals/substances, but with specific risks associated to their use. The European Commission has published a new Recommendation to clarify the definition of ‘nanomaterial’. This definition may serve different policy, legislative and research purposes when addressing materials or issues concerning products of nanotechnologies.

Read More »
cosmetic products

Expected Restriction on the Use of Methyl Salicylate

The European Commission has notified the World Trade Organization (WTO) of a draft amendment to the Regulation (EC) No. 1223/2009 on cosmetic products. Annex III to Regulation will be amended, and the use of Methyl Salicylate in cosmetic products will be restricted.

Read More »