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 Formaldehyde Threshold in Cosmetic Products

The European Commission has issued a draft regulation to amend the preamble of Annex V regarding the threshold for labelling formaldehyde releasers. This amendment results from a scientific advice published by the SCCS concluding that the current threshold does not sufficiently protect consumers sensitized to formaldehyde.

Read More »
cosmetic products

New Restriction on the Use of Benzophenone-3 in Cosmetics

Benzophenone-3 was part of a priority list of potential endocrine disruptors established by the European Commission in 2019. The SCCS was asked to assess the safety of this ingredient and the European Cosmetics Regulation will be amended in accordance with the SCCS assessment conclusions.

Read More »
endocrine disruptors
cosmetic products

European Commission Calls for Data on Ingredients with Potential Endocrine-Disrupting Properties

Substances classified as endocrine disruptors are compounds that can alter the functioning of the endocrine system and negatively affect the health of humans and animals. In 2019, the European Commission set out two lists of ingredients suspected of having endocrine disrupting properties. More recently, the Commission has published a call for data for 10 ingredients that were included in the low priority group (Group B) for the SCCS to be able to assess their safety.

Read More »
cosmetic products

SCCS Preliminary Opinion on Prostaglandins and Prostaglandin-analogues

Following the mandate from the European Commission, the Scientific Committee on Consumer Safety (SCCS) has published a preliminary opinion on Prostaglandins and Prostaglandin-analogues used in cosmetic products. This preliminary opinion is open for comments and the deadline was set for 23 november 2021.

Read More »
cosmetic products

SCCS Preliminary Opinion on Butylated Hydroxytoluene (BHT)

Following the mandate from the European Commission, the Scientific Committee on Consumer Safety (SCCS) has published a preliminary opinion on Butylated Hydroxytoluene (BHT). This preliminary opinion is open for comments and the deadline was set for 23 november 2021.

Read More »
cosmetic products

EU Prohibition of Zinc Pyrithione in Cosmetic Products

Zinc Pyrithione has been used for more than 60 years as an anti-dandruff agent in cosmetic products. Last month, the European Commission published the Commission Regulation (EU) 2021/1092, which includes this ingredient in Annex II. From March 2022 onwards, Zinc Pyrithione will be prohibited in cosmetic products.

Read More »
medical devices

EUDAMED Status Update 2021

The development and deployment of EUDAMED is progressing. Following the implementation plan and getting familiar with the information stored in the database’s modules is crucial for economic operators compliance in the EU market.

Read More »
cosmetic products

EU Chemicals Strategy for Sustainability

The Chemicals Strategy for Sustainability (CSS) was recently published by the European Union. The CSS is part of the European Green Deal which aims for a toxic-free environment leading to zero pollution. The initiative proposes a new legislative amend to the EU Cosmetic Products Regulation. Simplification and digitalization of labelling requirements plus review of the definition of nanomaterial are two of the main objectives of the CSS.

Read More »
cosmetic products

Nanotechnology in Sun Care Products

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. Currently, there are 4 nano-ingredients approved in the European Union for use as UV filters in cosmetic products.

Read More »
cosmetic products

May Butylphenyl Methylpropional be used in Cosmetic Products?

Butylphenyl Methylpropional, also known as Lilial, is a fragrance ingredient that has been used for years in several cosmetic and non-cosmetic products. Nevertheless, some concerns have been expressed regarding the use of this ingredient and its risk to consumers. According to an amendment to the CLP Regulation, the use of Butylphenyl Methylpropional will be prohibited in cosmetic products from 1st March 2022.

Read More »
cosmetic products

How are Cosmetic Products Regulated in the United Arab Emirates?

The United Arab Emirates (UAE) are an emerging market for the beauty industry. Cosmetics and personal care products supplied or sold in the UAE must comply with the health and safety requirements set out in UAE legislation. Overall, the process for importing a cosmetic product into the UAE market from the European Union can be quite straightforward since the UAE has aligned several of its requirements with the European Cosmetic Regulation.

Read More »