Amendment to the European Standard for Risk Management of Medical Devices
An European amendment to EN ISO 14971 - Medical devices - Application of risk management to medical devices, designated A11:2021, was published in December 2021, paving the way to the standard being listed in the Official Journal of the European Union (OJEU) as providing a presumption of conformity with the relevant requirements of the European Medical Device and In Vitro Diagnostics Regulations.

The amendment replaces the European foreword and adds two new Annexes – ZA and ZB – stating the relationship between the clauses of the standard and the requirements of the Medical Devices Regulation (MDR (EU) 2017/745) and In Vitro Diagnostics Regulation (IVDR (EU) 2017/746).

The MDR and IVDR present more detailed requirements for the risk management process compared with the previous Directives. On the whole, the harmonization of ISO 14971:2019 as EN ISO 14971:2019+Amd 11:2021 is great news for the Medical Device manufacturer as it shows a stronger relationship between the standard and the risk management process required in the Regulations.

There are no content deviations in the Z Annexes of EN ISO 14971:2019+A11:2021. The Z Annexes state that once the standard has been published in the OJEU, compliance with the standard will give a presumption of conformity with the relevant General Safety and Performance Requirements (GSPRs) of the MDR and IVDR.

Tables in Annex ZA and ZB show the relationship between the GSPRs in Annex I of each regulation with the clauses of EN ISO 14971. In particular, the tables address:

– GSPR 3 regarding the manufacturer’s risk management system;

– GSPR 4 regarding risk control measures;

– GSPR 5 regarding elimination or reduction of risks;

– GSPR 8 regarding known and foreseeable risks, and undesirable side-effects; and,

– GSPR 9 of the MDR regarding devices without a medical purpose.

In applying the standard considering new Annex Zs , it is important to note that:

– The tables indicate that, in regard to some of the requirements of the regulations, the standard covers the process requirements but not the device-specific execution of the process;

– The scope of application is limited to medical devices, accessories for a medical device as defined in the regulations and to products regulated as devices under the regulations;

– Z Annexes contain a number of explanatory notes stating that the manufacturer must comply with certain requirements of the MDR and IVDR which override any content of the standard;

– Annex ZA states that usability-specific aspects of applicable GSPRs are not covered. IEC 62366 covers usability of Medical Devices and it is expected to be harmonised in due course;

– The risk management process must comply with the requirement in the regulations that risks have to be reduced as far as possible and the manufacturer’s policy for establishing criteria for risk acceptability has to comply with the GSPRs of the regulations.


  1. EN ISO 14971:2019+A11:2021, on application of risk management to medical devices


cosmetic products

EU to set Labelling Requirements for 56 additional Fragrance Allergens in Cosmetic Products

World Trade Organization (WTO) has been notified by the European Commission of a draft amendment to Regulation (EC) No 1223/2009 as regards labelling of fragrance allergens in Cosmetic Products. The proposed date of adoption of the new regulation is expected to be in the first half of 2023 and the propose date of entry in force 20 days from the publication in the Official Journal of the European Union.

Read More »
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 »