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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

Important Updates on EUDAMED and Economic Operator Responsibilities!

The European Commission released some updates regarding EUDAMED, the European Database on Medical Devices. These updates pertain to the responsibilities of economic operators.

The update on the EUDAMED - release notes, section 2.1, reflects Article 31 §5 from MDR (EU) 2017/745 and Article 28 §5 from IVDR (EU) 2017/746:

Not later than one year after submission of the information in accordance with paragraph 1, and every second year thereafter, the economic operator shall confirm the accuracy of the data. In the event of a failure to do so within six months of those deadlines, any Member State may take appropriate corrective measures within its territory until that economic operator complies with that obligation.

Additionally, it is crucial for all manufacturers to note the requirements stated in Article 31 §4 from MDR (EU) 2017/745 and Article 28 §4 from IVDR (EU) 2017/746:

Within one week of any change occurring in relation to the information referred to in paragraph 1 of this Article, the economic operator shall update the data in the electronic system referred to in Article 30.

For a detailed step-by-step explanation, we highly recommend referring to the video in section 2.1.7 of the Economic Operators - user guide, which provides a comprehensive guide. To access the video, click here

Should you have any further questions or require additional information, please do not hesitate to reach out to us.

MDSS offers personalized support for a seamless introduction to EUDAMED. Schedule your session here.

Categories: News

Revision of MedDO and IVDO

New requirements for product groups without an intended medical purpose and alignment with Regulation (EU) 2023/607 on medical devices and in vitro diagnostic medical devices.

The Federal Council of Switzerland has decided to amend the Medical Devices Ordinance (MedDO) in alignment with EU requirements (Implementing Regulation 2023/1194), for product groups without an intended medical purpose.

The amendments on EU-MDR 2017/745, regarding changes to transitional periods for certificates, and on EU-MDR 2017/745 and EU-IVDR 2017/746, regarding the elimination of the sell-off period, were also transposed to the MedDO and IvDO. The approved amendments to the MedDO and IvDO will become effective on 1st November 2023.

More details can be found in the Swissmedic publication.

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

Flowchart for determining eligibility under the extended MDR transitional period for Devices

The Commission just published a Flowchart to assist manufacturers and stakeholders in determining device coverage under the extended transitional period of the MDR

The purpose of the flowchart is to aid manufacturers and other relevant stakeholders in making a determination about the inclusion of a device within the extended transitional period outlined in Article 120 of Regulation (EU) 2017/745 on medical devices (MDR), as revised by Regulation 2023/607. This flowchart is designed to facilitate the assessment of whether certain devices meet the criteria, adhere to the stipulated conditions, and meet the specified deadlines for the placing on the market or putting into service as outlined in Article 120 of the MDR. 

While using the flowchart you are advised to refer to the MDR text, which holds precedence over the flowchart, as well as to consult the Q&A addressing practical aspects related to the implementation of Regulation (EU) 2023/607. 

MDSS provides assistance in going through the flow chart or the Q&A to ensure the accurate application of the extension and the establishment and availability of the relevant documentation, which may be requested by authorities and other parties such as importers. 

Book your appointment here!

Categories: News

Important Update Regarding UK Medical Device Vigilance Reporting _MORE Portal

We would like to bring your attention to a significant change in the UK Vigilance reporting process that will be mandatory after August 31, 2023 in the UK (see our Newsletter dated April 26, 2023). 

The AICXML mailbox, which has played a vital role in reporting adverse incidents related to Medical Devices to the MHRA, will no longer be operational beyond August 31, 2023. It is being replaced by the MORE (Manufacturer Online Reporting) portal. It is essential to highlight that any submissions sent to after August 31, 2023, will not reach the MHRA. This could result in a failure to report, which is a critical noncompliance.

MDSS has been entrusted with the mandate to report Vigilance events by most of our clients. For these clients we have consistently utilized the MORE platform for reporting since its inception. During the transition, the MHRA actively sought feedback from users, and we are pleased to share that our inputs were taken into consideration to enhance the platform. 

For those of you who report directly as manufacturers, reporting via the MORE portal requires mandatory registration. Detailed instructions for both registration and submission through the portal, along with relevant guidance and useful links, can be found on the official GOV.UK website. We advise strict adherence to these guidelines. Furthermore, if you choose to report directly, it is crucial to keep MDSS, if we are your UK Responsible Person, informed of the submissions, as outlined in the guidance: "The manufacturer should also ensure that these guidelines are made known to their UK Responsible Person ..., who should be kept informed of incident reports. This will enable their UK Responsible Person ... to fulfil their obligations.

We are excited that we introduced the new portal seamlessly in our QM System for our clients to transition to the MORE portal, aligning with the guidelines to ensure a smooth and uninterrupted submission process. MDSS will continue to offer the submission of vigilance reports to the MHRA through the MORE portal specifically for its clients. 

We value your feedback and would greatly appreciate your thoughts on the helpfulness of this Newsletter in the comment section below.

Categories: News

UK MDR Update published!

It is finally official! The Medical Devices (Amendment) (Great Britain) Regulations 2023 - statutory instrument 2023 No. 677 will come into force on July 1, 2023.

You can find the legal text on this link.

The UK government has extended the acceptance of CE marked medical devices on the Great Britain market. This legislation will provide that CE marked medical devices may be placed on the Great Britain market to the following timelines:

  • general medical devices compliant with the EU medical devices directive (EU MDD) or EU active implantable medical devices directive (EU AIMDD) with a valid declaration and CE marking can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2028
  • in vitro diagnostic medical devices (IVDs) compliant with the EU in vitro diagnostic medical devices directive (EU IVDD) can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2030, and
  • general medical devices, including custom-made devices, compliant with the EU medical devices regulation (EU MDR) and IVDs compliant with the EU in vitro diagnostic medical devices regulation (EU IVDR) can be placed on the Great Britain market up until the 30 June 2030.

The legislation provides that you can place self-declared CE marked Class I medical devices on the GB market beyond 30 June 2023 if they are:

  • self-declared against EU MDR requirements (until 30 June 2030), or
  • self-declared against MDD requirements before 26 May 2021 where Notified Body involvement in their assessment is not required under MDD but is under EU MDR (until 30 June 2028). This includes upclassified devices and reusable surgical instruments.

It also provides that you can place a Class I medical device which has a sterile or measuring function with a valid MDD certificate on the GB market until 30 June 2028.

Class I medical devices and general IVDs under the Directives, for which the conformity assessment under the EU MDD or EU IVDD did not require a notified body, can only be placed on the Great Britain market if the involvement of a notified body would be required under the EU MDR or IVDR (i.e., if it is an upclassified device or a reusable surgical instrument Class I device). 

You can download the timelines for placement of CE marked medical devices on the Great Britain market under the Medical Devices (Amendment) (Great Britain) Regulations 2023 here.

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

MHRA guidance on Regulating medical devices in the UK has been updated!

The MHRA has updated their guidance on "Regulating medical devices in the UK" with changes to some key topics: ‘Summary of key requirements for placing a device on the Great Britain market’, ‘Registrations in Great Britain’, ‘UKCA marking’, ‘CE marking and Notified Bodies’, ‘Labelling requirements’ and ‘Regulation of medical devices in Northern Ireland’ Reference Guides.

We want to draw your attention to "Register medical devices to place on the market", which provides a very detailed guidance on "Registration of certain medical devices that have expired/expiring CE certificates" and "Registration of certain medical devices which are EU MDD Class I reusable surgical instruments or EU MDD Class I medical devices upclassified from Class I". 

You can access the guidance document for these specific situations here.

If you find yourself in any of these scenarios, please do not hesitate to reach out to us, and we will provide you with the necessary assistance to navigate this process.

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Categories: News

MHRA extended the transition period for MORE!

The MHRA has extended the deadline for full transitioning to the new MORE (On-line Reporting Environment) portal until 31 August 2023. Until the end of August submissions of vigilance reports via will still be possible. It seems feedback from actors has been received which led to the extension. However, it is recommended to make yourselves familiar with the new MORE portal as soon as possible to identify any issues with the database. The MHRA vigilance guidance was updated accordingly to reflect this information.

Please note: Reports from the old MORE account should still be downloaded until the end of April! From 1 May the old MORE portal will allow read-only access.

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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

Swissmedic inspects Class I manufacturers in Switzerland!

Swissmedic evaluated compliance declarations from a random sample of 27 Swiss manufacturers of Class I medical devices between August and December 2022. The results revealed poor performance among manufacturers, with 70% of post-market surveillance (PMS) documentation failing to meet legal standards!

Furthermore, 14% of the manufacturers were not registered with Swissmedic, 39% of verified Class I devices were not notified correctly and 11% were unable to demonstrate compliance with new legal requirements.

Swiss Medtech urges all Class I medical device manufacturers to promptly assess and correct any compliance issues to comply with legal requirements.

Here you can find the full report.

According to the report, Swissmedic has initiated a focus campaign to assess the implementation of the new regulation for class I devices, which are not monitored by a Notified Body. Similar campaigns are also expected in the EU, as outlined in section 3 of the MDR, which details the market surveillance requirements for the Competent Authorities. Article 93 states:

  1. The competent authorities shall perform appropriate checks on the conformity characteristics and performance of devices …
  2. The competent authorities shall draw up annual surveillance activity plans …

It is important to note that the surveillance activities of Swissmedic and other EU authorities will not be limited to risk class I devices/manufacturers. MDSS anticipates that such investigations will continue in the coming years as manufacturers adjust to the new regulation. Therefore, the Swissmedic investigation in 2023 should come as no surprise, especially for class I products that should have been complying since May 2021.

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Categories: News

Official Q&A on the extension of the MDR published!

BSI supports its clients with their own FAQ

We are pleased to announce that the highly anticipated Q&A clarifying several aspects regarding the latest extension (Regulation (EU)2023/607) has been published.
We would also like to thank our clients for their valuable feedback, which greatly contributed to the success of last week's MDSS Seminar. During the seminar, we covered a number of important aspects, with the most pressing question being - when can products can be sold again??? This topic has been addressed in Question 7 of the Q&A: “The extension of the transitional period and the concomitant extension of the certificate’s validity is done automatically by law, …” (subject to certain conditions).

Another important question raised during the seminar was - how to demonstrate the validity of an expired Certificate??? In response to this, Question 7 offers several options:

  • Self Declaration based on a harmonized Template
    • MDSS comment: It would be beneficial if the Commission could publish this template. Alternatively, one could seek help from prominent trade associations in the EU who may have a proposal.
  • Confirmation letter issued by the NB acknowledging the receipt of the application and confirming the written agreement is in place, without incurring any extra cost;
    • MDSS comment: The NBs work together on such a letter. However, this letter may not cover all the conditions. The NBs have not received the task to check and confirm that conditions are met due to their constraints in resources.
  • The CA should be able to issue Free Sales Certificates;  
    • MDSS comment: This could potentially be the most effective approach. The CA would likely conduct checks to ensure that the conditions are met, rather than solely relying on self-declaration
  • The Commission will update its factsheets for CA outside the EU;
    • MDSS comment: This could support the manufacturer, however, a third country may still wish to verify that the conditions are met.

We are also excited to inform you that we are working on a one-step approach that will enable the Authorized Representative to support the manufacturer with a single document indicating that all necessary conditions have been checked and confirmed. This will provide our clients with a much-needed solution and will be available in the near future.

BSI has issued their own FAQ, which focuses on the involvement of the NB. They have confirmed that they are working with other NBs on a harmonized letter and have advised those who switched back  or consider to switch back to the BSI normal service, due to the extension, that they will find themselves back in line. 

We remain committed to supporting our clients and will continue to provide updates as they become available. 

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Categories: News

Have your say!

EU proposes Master UDI for contact lenses

The European Union has introduced a new initiative for a Master Unique Device  Identification (UDI) Device Identifier (DI) (Master UDI-DI) for highly individualized contact lenses. The UDI system is designed to improve traceability and accountability for medical devices, including contact lenses. This proposal is product-specific and seeks to streamline the registration process for manufacturers and improve patient safety. Feedback on the proposed Master UDI-DI may be provided  until April 19th. 

The proposed Master UDI-DI for highly individualized contact lenses is a significant step forward in medical device regulation. Under this initiative, not every individual lens would be assigned a UDI-DI.  Lenses will be grouped with a Master UDI-DI. “Master UDI-DI is intended as the identifier of a group of highly individualized devices (i.e. contact lenses) presenting specific similarities with respect to defined clinically relevant Parameters”.

While this initiative is specific to contact lenses, it raises questions about the potential for a Master UDI-DI for other highly individualized medical devices. The European Commission has already received comments on this initiative, and if your products fall under a similar category, it may be worth considering commenting on the proposed Master UDI-DI.

 As with any new regulation, it is essential to stay informed and up-to-date. Delegated acts can be found on the Commission websiteBefore assigning a UDI and registering your product in Eudamed, it is recommended that you check whether there are any Master UDI-DI requirements for similar products. 

Don't miss the opportunity to provide feedback on this proposed regulation. Comments are open until April 19th, so be sure to have your say on this important matter!

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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

New Features and Improvements in EUDAMED Production v 2.10

EUDAMED Production v 2.10 has been released with several new features and improvements.

Are you ready for the latest and greatest version of EUDAMED Production? Look no further than version 2.10, which comes with a range of exciting new features and improvements. In this post, we'll provide you with a brief overview of what's new, including updates to the Actors module, UDI/Device module, NB & Certificates module, and DTX.

One of the key features in the Actors module is the ability to set an Economic Operator as inactive, which creates a new version of the Economic Operator with the new status. The UDI/Device module now allows you to search for devices by indicating the Competent Authority (CA) responsible for the manufacturer, while the NB & Certificates module lets you register refused certificates, refused applications, and withdrawn applications of type product.

In addition to these exciting new features, EUDAMED Production v 2.10 also includes several user experience and user interface improvements, various fixes, and updates to the DTX. So if you want to operate more efficiently in EUDAMED, be sure to upgrade to the latest version today. Read the full document here.

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

Categories: News
  • UK Responsible Person

    6 Wilmslow Road, Rusholme, Manchester M14 5TP, UK

    +44 7898 375115

  • U.S. Agent

    IL 60630

    +1 (312) 975-1694

  • Cosmetics Responsible Person

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  • CH-REP

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    5000 Aarau

  • Importer

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Schiffgraben 41
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