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Historic deal reached on World's first AI Regulations - The Artificial Intelligence Act! 

The Council presidency and negotiators from the European Parliament have achieved a preliminary accord on the proposal for harmonized regulations governing artificial intelligence (AI), known as the Artificial Intelligence Act.

This drafted regulation is designed to guarantee the safety of AI systems introduced to the European market and used within the EU, emphasizing the adherence to fundamental rights and European values.

This groundbreaking proposal not only prioritizes safety but also seeks to bolster investment and foster innovation in AI across Europe.

The AI act stands as a pivotal legislative endeavor poised to encourage the advancement and widespread acceptance of safe and reliable AI throughout the EU's unified market, engaging both private enterprises and public entities. Its primary objective is to govern AI systems based on their potential to pose societal harm, employing a 'risk-based' strategy: greater risks warrant more stringent regulations. As an unprecedented legislative initiative globally, this act has the capacity to establish a universal benchmark for AI regulation, akin to the impact of the GDPR, thereby advocating the European model of tech regulation on a global scale.

Here is the press release from the Council of the EU with detailed information.

Categories: News

EU survey alert: Share your thoughts on medical device regulations (MDR/IVDR)!

EC survey for MD and IVD manufacturers and AR on the status of the MDR/IVDR implementation!

This survey is being endorsed by the European Commission (DG SANTE/HaDEA) to gather information and data regarding the progress of implementing Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).

We urge all our clients, including those intending to introduce products to the EU/EEA market within the next two years, to support this effort by participating in the survey! 

The goal is to gain an accurate understanding of the status of MDR/IVDR implementation, and your input is incredibly valuable. The European Commission seeks information, also concerning orphan devices and low-volume medical devices that might vanish from the EU market. This data will guide future directions and the implementation of necessary measures.
Here is the PDF version of the survey along with the endorsement letter from the European Commission.

Link to the survey

Survey deadline: 15 January 2024 (23:59 CET)


Webinar with the study team with details on the survey background and the survey structure: 

Thursday, 7 December 2023*, 1-2pm CET (no registration needed) 

Meeting ID: 851 6917 8337, Passcode: 442308

*another webinar is likely to take place in the near future

Categories: News

Medtech Europe position paper on the future of Europe's Medical Technology Regulations!

MedTech Europe is outlining the obstacles that medical technologies encounter within the European regulatory framework. 

According to the latest information, there are more than 35,000 medical technology companies in Europe, with 92% of them being small and medium-sized enterprises (SMEs). These companies currently offer approximately 500,000 medical technologies to European patients. It is anticipated that at least 17% of current In Vitro Diagnostics (IVDs) and 20% of Medical Device (MD) portfolios will be discontinued in Europe. This is attributed to the expectation that the costs associated with transitioning to the In Vitro Diagnostic Regulation (IVDR) or Medical Device Regulation (MDR) will outweigh product revenue, particularly for SMEs. Additionally, 28% of In Vitro Diagnostic (IVD) manufacturers and 48% of medical device manufacturers are either deprioritizing or planning to deprioritize the EU market as their first choice for regulatory clearance due to these challenges.

The position paper presents a three-point vision for what a prospective system could resemble. This vision is accompanied by suggested solutions to initiate discussions among all affected parties regarding the necessary changes to improve the current system.

In the face of evolving regulatory challenges for medical technology companies in Europe, our specialized services are tailored to provide comprehensive assistance, guiding businesses through the intricacies of compliance with the MDR and IVDR. 

Contact us to ensure a smooth transition, and let our expertise support your journey towards regulatory success.

Categories: News

Manual on borderline and classification for medical devices under MDR & IVDR!

A new version was just published. This manual serves as a valuable resource for understanding classification rules and define whether your product qualifies as a medical device. In case you encounter a classification disagreement and seek illustrative examples, this manual is your go-to resource. The reasoning provided here may also offer additional insights for assessing other products. 

Categories: News

Advantages of conducting business in the UK. Possible under the MDR?

There are potential advantages of conducting business in the UK. The pressing question is: Can this also be achieved within the framework of the Medical Device Regulation (MDR)?

In instances where a virtual manufacturer lacks product design rights, both the UK Approved Body/EU Notified Body and the MHRA may consider a technical file from them, even if it contains redacted proprietary information. This is acceptable as long as the redacted details are not crucial for the UK Approved Body/EU Notified Body or the MHRA to assess the device's compliance with regulatory standards. It is advised to keep redactions to a minimum.

For virtual manufacturers holding redacted technical documentation, it is imperative to establish contractual arrangements, which ensures that the original equipment manufacturer (OEM) directly discloses all pertinent information to the UK Approved Body/EU Notified Body of the virtual manufacturer.

More detailed information can be found in the MHRA Guidance.

This is an additional solution to do business in the UK and should be carefully considered if the opportunity arises. Nonetheless, it is imperative to approach this as a strategic business discussion, as it allows your customer to market your products under their name as the virtual manufacturer. This move may introduce new business risks that need thorough evaluation.

The shortcomings of the past MDD did lead to the new rules in the EU with the MDR. Consequently, it makes the solution of virtual manufacturer impossible to apply without disclosing your secrets to your customer. The situation in the UK, however, presents a different scenario, as the UK still applies mostly MDD rules. However, even within the MDD framework, the EU had already taken a distinct stance on this issue, whereas the UK MHRA was more thoughtful of this matter.

Therefore, it is worth highlighting that the MHRA exhibits a pragmatic approach to this issue, aligning with their pragmatic approach to various other aspects.

Categories: News

Notified Body Confirmation Letter is published! Free of charge.

We are pleased to announce the publication of the Notified Body Confirmation Letter! This letter is an essential document that manufacturers can use to demonstrate the extension of the additional transitional period for their legacy devices with expired MDD certificates, as permitted by the regulation EU 2023/607 amending the Medical Device Regulation (MDR).

The European Commission has provided helpful guidance in Question 7 of the Q&A document, available at this link. Among other solutions, additional evidence could be provided by a confirmation letter issued by the notified body. While some notified bodies may have reservations about the last sentence of their involvement, it is important to note that they have collaborated extensively to create a harmonized version of the confirmation letter. You can find the harmonized template here.

With the last sentence, the Commission has suggested that this confirmation letter be provided free of charge "Such confirmation letter could be based on a harmonised template and be issued, in principle, without extra costs". However, it is important to recognize that while the letter itself may not incur an additional cost, notified bodies may have different pricing structures throughout the MDR certification process. 

We appreciate the diligent efforts of Team NB in promptly developing a harmonized template for the confirmation letter. This standardized approach will help ensure clarity and consistency for manufacturers seeking to benefit from the extension of the transitional period for their legacy devices. 

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Categories: News

The UK and Switzerland have embraced the EU MDR extension!

The EU currently leads the way in regulatory standards, with the UK and Switzerland following suit. This is being done for valid reasons, as medical devices may not be available in these markets due to the same reasons. Overall, these are excellent news for the medical devices industry.

However, these countries may not want to rely heavily on the EU approval process. This situation could rapidly change in the future, particularly, as the UK will transition to its own law (with a transition period for CE marking) and with the UKRP in place, while Switzerland will accept FDA with the CH-REP in place. Once this happens, both countries will no longer depend on the EU for their supply of compliant medical devices.

While some may see this as a positive development, historically, different regulatory markets have been used to protect domestic industries, which has not been conducive to the overall prosperity of a region. It remains to be seen how this will play out in the medical device industry. Are we going to see protectionist measures in the future? Only time will tell.

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Categories: News

Extension of the MDR for legacy devices!

On February 16, 2023, the European Parliament adopted the extension of the transition period for the EU MDR and to extend the validity of certain device certificates (here is  MDSS' outline on the proposal extension and on Article 97). See how Switzerland and the UK reacted in their official pages.

*The adopted proposal still has to go through the legislative procedure to be adopted as law!

Join our Online Seminar where we will discuss the extension and the impact of Article 97 and address how Switzerland and the UK are acting!

Categories: News

It's time for EUDAMED!

National Authorities improve their vigilance systems, but that is far from harmonization.

It makes the system even more complicated if every authority creates their own reporting system. Such changes don’t make it easier to keep EU and non-EU manufacturers selling their devices in Europe. 

See the new e-service for vigilance submissions for Sweden. This website should be used for submissions until EUDAMED is mandatory for vigilance. No registration is required. 

For more news and updates from the medical device industry, be sure to check out MDSS News & Views.

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Categories: News

Key Terms and Concepts in the Medical Device Regulation - Vigilance

The vigilance requirements under the EU's medical device regulations can be complex and confusing. To help you navigate this landscape, the Medical Device Coordination Group (MDCG) has released a guide to key terms and concepts in Chapter VII of the Regulation (EU) 2017/745 on medical devices (MDR).

This guide is a valuable resource for anyone involved in the medical device industry, including competent authorities and economic operators. It establishes a common understanding of important definitions and concepts necessary for effective implementation of vigilance requirements.

The guide includes definitions from the Guidelines on a Medical Devices Vigilance System, modified where necessary for alignment with the MDR. It covers medical devices, accessories for medical devices, and products listed in Annex XVI to the MDR.

While the guide is non-exhaustive, it should be read in conjunction with the MDR, relevant standards, and other MDCG guidance documents. Note that terms and concepts outlined in the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) are outside the scope of this guide.

In conclusion, our guide to key terms and concepts in the MDR is a must-read for anyone looking to understand the vigilance requirements under the EU's medical device regulations. Access this valuable resource to gain a clear understanding of these requirements and ensure effective implementation.

Download the document here: Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices .

For more news and updates from the medical device industry, be sure to check out MDSS News & Views.

Categories: News
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