Critical Catalyst

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Critical Catalyst

We are a team of specialised consultants in regulatory affairs for the medical apps, medical devices

01/07/2024

Is Aluminium in cosmetics safe for human health ❓

The SCCS has issued its Final Opinion on Aluminium safety in cosmetics. Safe use levels:

◦ Non-spray deodorants/antiperspirants: 6.25%

◦ Spray deodorants/antiperspirants: 10.60%

◦ Toothpaste: 2.65%

◦ Lipstick: 14%

Read full article: https://shorturl.at/IQfga

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Será o alumínio em cosméticos seguro para a saúde humana ❓💄

O SCCS emitiu a sua Opinião Final sobre a segurança do alumínio em cosméticos. Concentrações consideradas seguras:

- Desodorizantes/antitranspirantes não aerossóis: 6,25%

- Desodorizantes/antitranspirantes em aerossol: 10,60%

- Pasta de dentes: 2,65%

- Batom: 14%

Protetores solares em aerossol e formas nano de alumínio estão excluídos desta opinião.

Leia o artigo completo: https://shorturl.at/IQfga

30/03/2023

The MDCG 2022-19 indicates a series of templates that should be used for performance study applications under the , while the respective module is not fully functional.

You can check below the required documents for application and notification of a Performance Study under the EU IVDR.

https://criticalcatalyst.com/application-and-notification-of-a-performance-study-under-the-eu-ivdr-required-documents/

18/03/2023

🇮🇹 Ready to start our 3rd day at . It is great to meet long time business partners, revisit friends and colleagues, all in the same place. What an exciting time to be in this Industry!

Thank you to our Partners for their outstanding and heartwarming reception so far. Your work and commitment is inspiring!

And a big shout out to our Regulatory Affairs team! You are doing an amazing job, we are very proud! 🙌

If you want to know more about our work, feel free to contact us. We will be glad to meet you during these last remaining days of .

27/02/2023

Safety reporting in clinical investigations of medical devices shall be performed in line with Article 80(2) of the .

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 .

However, on October 2022 the Medical Device Coordination Group ( ) 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.

https://criticalcatalyst.com/safety-reporting-in-clinical-investigations-a-gap-analysis-of-guidance-documents/

15/02/2023

If a medical device manufacturer is not established in a Member State, the devices can only be placed on the European 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 and , but clarification of relevant requirements is described in MDCG 2022-16 of October 2022.

https://criticalcatalyst.com/roles-and-responsibilities-of-an-authorised-representative-under-eu-mdr-and-ivdr/

14/02/2023

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?

https://criticalcatalyst.com/understanding-the-iso-standards-lifecycle/

24/01/2023

The Commission published the Implementing Regulation (EU) 2022/2347, laying down rules for the reclassification of several active products without an intended medical purpose mentioned in MDR annex XVI.

https://criticalcatalyst.com/reclassification-of-active-products-without-intended-medical-purpose/

23/01/2023

The European Union Court of Justice repealed the French requirement for the labelling of the precautionary measurement “Not to be used on the nappy-skin area of children under 3 years of age” on leave-on cosmetic products containing Phenoxyethanol. The labelling restriction related to Phenoxyethanol is no longer mandatory for products imported into France.

Read more @ https://criticalcatalyst.com/french-labelling-requirement-for-leave-on-products-containing-phenoxyethanol-repealed/

09/01/2023

The European Commission just proposed a set of amendments aimed to maintain patients’ access to a wide range of medical devices while ensuring the transition to the new and 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.

https://criticalcatalyst.com/amendments-to-the-transitional-provisions-of-the-european-union-mdr-and-ivdr/

16/12/2022

EU MDR Article 97 may be a temporary solution to avoid disruption of supply of on the Market. The MDCG 2022-18 presents a uniform approach for application of 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.

https://criticalcatalyst.com/mdcg-2022-18-eu-mdr-article-97/

13/12/2022

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.

https://criticalcatalyst.com/eu-mdr-proposal-for-extension-of-transition-period/

12/08/2022

Implementation of the in the is a top priority for the medical devices industry, which has committed significant resources to comply with the new requirements. In accordance with MedTech Europe latest survey report, despite its efforts, the sector remains seriously held back by the slow and piecemeal implementation of the new regulatory framework.

For more information, read our post our contact us at info@criticalcatalyst.com.

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