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


medical devices

Safety Reporting in Clinical Investigations: a Gap Analysis of Guidance Documents 

Safety reporting in clinical investigations of medical devices shall be performed in line with Article 80(2) of the EU MDR. On May 2020, it was published the MDCG 2020-10/1, outlining the procedures for safety reporting in clinical investigations of medical devices under the EU MDR. However, on October 2022 the Medical Device Coordination Group (MDCG) published an updated version of the MDCG 2020-10/1, the MDCG 2020-10/1 Rev 1. This article highlights the updates included in the new revision, analysing the gaps between both documents.

Read More »
medical devices

Roles and Responsibilities of an Authorised Representative under EU MDR and IVDR 

If a medical device manufacturer is not established in a Member State, the devices can only be placed on the Union market if the manufacturer designates an authorised representative. The authorised representative plays a pivotal role in ensuring the compliance of the devices with EU regulation, serving as point of contact. The obligations and responsibilities of authorised representative are outlined on Article 11 of both MDR and IVDR, but clarification of relevant requirements is described in MDCG 2022-16 of October 2022.

Read More »
medical devices

Understanding the ISO Standards Lifecycle

ISO Standards cover a huge range of activities, representing the distilled wisdom of people with expertise in their subject matter and providing the regulators with a sound basis to develop better legislation. ISO Standards are diverse, addressing from the shoe size we wear to the quality of air we breathe. The medical device sector is no exception. ISO has many International Standards and guidance documents aimed at helping the sector ensure safe and effective medical devices while meeting the multitude of national, regional and international regulatory requirements. But how exactly is a Standard developed, reviewed and withdraw?

Read More »
medical devices

Amendments to the Transitional Provisions of the European Union MDR and IVDR

The proposed amendments aim to maintain patients’ access to a wide range of medical devices while ensuring the transition to the new framework. The ammendments proposal aims to extend the current transition period (Article 120 of the MDR), and it also deletes the ‘sell-off’ deadlines of both MDR and IVDR. The extension is staggered depending on the risk class of the device – until December 2027 for high-risk devices and December 2028 for medium and lower-risk devices.

Read More »
medical devices

EU MDR – Proposal for Extension of Transition Period

The transition to MDR has been slower than anticipated by the European Commission. Insufficient capacity of notified bodies and the low level of preparedness of manufacturers led to a proposal for extension of current MDR transition period with deadlines depending on the risk class of the devices.

Read More »
medical devices

MDCG 2022-18 – EU MDR Article 97

EU MDR Article 97 may be a temporary solution to avoid disruption of supply of Medical Devices on the EU Market. The MDCG 2022-18 presents a uniform approach for application of MDR Article 97 on non-compliant legacy devices under the conditions set by the competent authorities, while limiting the impact on the supply of safe and effective devices.

Read More »
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 »