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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
Tags: EU Notified Body

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
Tags: UK MHRA

New timelines for CE marked medical devices to continue to be placed on the Great Britain market!

The UK government intends to extend acceptance of CE marked devices in Great Britain beyond 30 June 2023! 

Subject to Parliamentary approval, the UK plan is to to introduce legislation before 30 June 2023, which will establish new significant timelines for CE marked medical devices to continue to be placed on the Great Britain market:

  • 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 sooner of expiry of certificate or 30 June 2030.

Here is the link to the updated Implementation of the Future Regulations.

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Categories: News
Tags: UK MHRA

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 AICxml@mhra.gov.uk 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
Tags: UK MORE

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
Tags: EU UK Switzerland

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
Tags: Swissmedic Switzerland

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
Tags: MDR European Commission

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 website. Before 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
Tags: European Commission UDI

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
Tags: EU MDR IVDR UK Switzerland

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
Tags: EU EUDAMED

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
Tags: MDR EUDAMED IVDR European Commission

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
Tags: MDR Vigilance EU MDCG

MDCG Guidance Document on IVD classification

If you're involved in the manufacture or sale of in vitro diagnostic medical devices (IVDs) in the European Union, you'll want to familiarize yourself with the MDCG guidance document on IVD classification. This document (second revision), developed by a group of experts representing Member State Competent Authorities, Commission services, notified bodies, and industry, provides guidance on how to classify an IVD prior to placing it on the market.

The guidance document covers the classification rules as set out under Annex VIII of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), as well as diagnostic or information society services performed on EU patients or devices put into service through distance sales. It also takes into account the Corrigendum published in the Official Journal of the European Union on 27 December 2019.

The primary purpose of the guidance document is to ensure the uniform application of the relevant regulatory provisions. It is intended to provide useful information for manufacturers, notified bodies, and health institutions on how to classify an IVD prior to placing it on the market. It also serves as a resource for regulators and other stakeholders when assessing the class attributed to an IVD. Examples in the document are provided for illustrative purposes only and do not represent an exhaustive list.

The guidance document should always be read in conjunction with the IVDR. By following the guidelines set out in the MDCG guidance document on IVD classification, you can ensure regulatory compliance and avoid potential issues down the line. This is particularly important given the legal empowerment for the classification of IVDs set out in the IVDR. 

The guidance document is an essential resource for anyone involved in the manufacture or sale of IVDs in the EU. In summary, the MDCG guidance document on IVD classification is an essential resource for anyone involved in the manufacture or sale of IVDs in the EU. 

By following the guidelines set out in the document, you can ensure regulatory compliance and avoid potential issues. Make sure to read the document in conjunction with the IVDR and refer to it whenever necessary.

Download the full article here: MDCG guidance document on IVD classification.

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

Categories: News
Tags: MDCG IVDR IVD

Understanding the Clinical Evaluation Consultation Procedure Under EU's MDR Regulation

The EU's Medical Device Regulation (MDR) has brought new requirements for the conformity assessment of high-risk medical devices. This regulation includes the implementation of the Clinical Evaluation Consultation Procedure (CECP) for certain class III implantable devices and class IIb active devices intended to administer and/or remove a medicinal product. The CECP is an important procedure that provides independent scientific opinions on the clinical evaluation assessment report, which is critical for manufacturers to receive valuable feedback and improve their products. 

It's essential for manufacturers to stay informed and compliant with the requirements of the MDR as it comes into effect. From April 2021 to June 2022;

  • 215 notifications were sent by notified bodies (NBs) under Article 54(3) of the EU's MDR.
  • 24 devices (11.2%) were subject to the CECP
  • While 191 devices (88.9%) were exempt from the CECP according to Article 54(2)b.
  • The experts screened 24 CECP applications and provided an opinion for 6 out of the 24 CECP applications received (25%).
  • On June 30, 2022, 5 opinions were delivered by the expert panels, and one opinion was still under development. The secretariat did not receive any justification from NBs not following the advice provided by the expert panel.

The implementation of the CECP under the EU's MDR regulation is a significant development in the medical device industry. It will bring higher levels of safety and quality to medical devices, ensuring that they meet the required standards.

This will provide peace of mind to patients and healthcare professionals, who can rely on the safety and quality of medical devices. In conclusion, it's crucial for manufacturers to stay informed and up-to-date with the requirements of the CECP under the EU's MDR regulation. The CECP will play a critical role in ensuring the safety and quality of medical devices and provide valuable feedback to manufacturers.

Do you think the implementation of the CECP will have a positive impact on the medical device industry and the safety of medical devices? 

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

Categories: News
Tags: MDR Clinical Evaluation

Handling of Certification Gaps according to MDCG 2022-18

The Medical Device Coordination Group (MDCG) has released a new document that provides guidance on handling certification gaps for medical devices in the EU/EEA. The document, MDCG 2022-18, addresses the procedures for handling certification gaps for medical devices in the EU/EEA and provides guidance on market surveillance procedures for member states...

Overview: Handling of Certification Gaps according to MDCG 2022-18 in Switzerland

MDCG 2022-18 outlines the procedures for handling certification gaps for medical devices in the EU/EEA. The document provides guidance on the steps that should be taken by member states to ensure that medical devices are safe and effective. It also addresses the procedures for market surveillance and the measures that should be taken by market surveillance authorities in the event of a certification gap.

Reliance on MDCG 2022-18 Confirmations of EU/EEA Member States

MDCG 2022-18 also provides guidance on the reliance on confirmations of EU/EEA member states. The document states that member states should rely on the confirmations of other EU/EEA member states when assessing the safety and effectiveness of medical devices. This helps to ensure that medical devices are safe and effective

Market Surveillance Procedures according to MDCG 2022-18 in Switzerland

MDCG 2022-18 also provides guidance on market surveillance procedures for member states. In Switzerland, the procedure for market surveillance is outlined in the document, including the steps that should be taken by market surveillance authorities in the event of a certification gap.

Surveillance and Measures by Swiss Market Surveillance Authorities

The document also addresses the surveillance and measures that should be taken by market surveillance authorities in Switzerland. This includes procedures for monitoring the market for medical devices and taking appropriate measures in the event of a certification gap.

Free Sales Certificates

MDCG 2022-18 also provides guidance on the issuance of free sales certificates for medical devices. This includes the conditions that must be met for a device to qualify for a free sales certificate and the procedures for issuing the certificate.

Frequently Asked Questions

The document also includes a section with frequently asked questions about the handling of certification gaps for medical devices in the EU/EEA. This provides additional information and clarification on the procedures outlined in the document.

You can download the document here.

Don't miss out on this important information and stay updated with the latest guidelines on handling certification gaps for medical devices in the EU/EEA. Follow our Linkedin account.

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

Categories: News
Tags: MDCG MDR IVDR Swissmedic Switzerland

Standard Fees for Notified Bodies under MDR and IVDR

The Medical Device Coordination Group (MDCG) has released a new document, MDCG 2023-2

This document, endorsed by the Medical Device Coordination Group (MDCG), outlines the standard fees for conformity assessment activities carried out by notified bodies. This document is intended to help notified bodies establish their own lists of standard fees for these activities and make them publicly available, as required by the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR).

The MDCG explains that standard fees should be made directly and easily accessible on the website of the notified body, and should be written in the same language as the website. Additionally, the MDCG provides templates for the "List of Standard Fees" to assist notified bodies in defining their own fees for conformity assessment activities. These fees can include flat fees, hourly fees, and fees based on the specific type of activity being performed.

The MDCG clarifies the meaning of “publicly available”, which “implies that a member of the public can access this information at any point in time, without the need for additional steps.” This means that the list of fees should be easily accessible on the website of the notified body without any additional steps, for example, without the need to register as a user of the website or provide contact data. The format of the standard fee table could be any that is accessible on a common website browser.

Moreover, the currency shown should be relevant to the country where the notified body has its registered place of business. If there are regional differences in fees charged depending on the location of the manufacturer, this should also be indicated.

In conclusion, the document serves as an important guide for notified bodies to establish their own fees for conformity assessment activities in line with the MDR and IVDR regulations. The goal of this document is to provide greater transparency and fairness in the fees charged by notified bodies for their conformity assessment services.

Download the article here.

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

Also available in www.youregulate.com ...

Categories: News
Tags: MDR IVDR MDCG

Proposal for amending the medical devices transition - feedback open!

Commission proposal for a Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices is open for feedback until January 18, 2023. All feedback received will be summarised by the Commission and presented to the Parliament and Council with the aim of feeding into the legislative debate. 

MDSS' already submitted feedback and our proposal would allow all legacy products to enter the MDR process immediately. See here our feedback and give your own opinion to the Commission here.

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Categories: News
Tags: European Commission MDR IVDR

Proposal for amending the medical devices transition extension was published! 

The proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices was adopted on January 6, 2023 by the Commission. The Parliament and the Council will now have to adopt the proposal via an accelerated co-decision procedure. 

See here the official press released and here the proposal.

Key elements of the proposal according to the Commission press release:

  • For medical devices covered by MDR Article 120.3, the transition period to the new rules is extended from 26 May 2024 to 31 December 2027 for higher risk devices and until 31 December 2028 for medium and lower risk devices. The extension will be subject to certain conditions, so that only devices that are safe and for which manufacturers have already taken steps to transition to the rules provided for by the Medical Devices Regulation will benefit from the additional time.
  • The proposal introduces a transition period until 26 May 2026 also for class III implantable custom-made devices, giving their manufacturers more time to obtain certification by a notified body. Also in this case, the transition period is subject to the application of the manufacturer for a conformity assessment of devices of this type before 26 May 2024.
  • To reflect the transition periods put forward by these amendments, the proposal extends the validity of certificates issued up until 26 May 2021, the day when the Medical Devices Regulation became applicable.
  • The Commission also proposes to remove the ‘sell-off' date currently established in the Medical Devices Regulation and in the In Vitro Diagnostic Medical Devices Regulation. The ‘sell-off' date is the end date after which devices that have already been placed on the market, and remain available for purchase, should be withdrawn. Removing this ‘sell-off' date will ensure that safe and essential medical devices that are already on the market remain available to healthcare systems and to patients in need.

For the next steps, the proposal still has to go through the legislative procedure to be adopted as law!

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Categories: News
Tags: European Commission MDR IVDR

Products without an intended medical purpose!

The regulation (EU) 2022/2346, released on 1 December 2022, lays down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745.

The transitional provision are explained in Article 2 and 3. Some provisions will enter into force on 22 December 2022. Here you can find the whole document.

The provisions in this document may provide a taste for the new transition of all other legacy products discussed here last week. If we apply this, then certificates may safely expire, however, a Notified Body will need to be engaged for surveillance activities. This can be your current MDD Notified Body or your new MDR Notified Body. 

Can this be even more complicated?? In any case, we are just curious about the cut-off date. 

An early date would be good for many manufacturers, however, it may already be too late for some other manufactures who stopped their products and disengaged from a Notified Body.   

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Categories: News
Tags: MDR European Commission

MORE Portal - UK!

The new MORE (Manufacturer's On-line Reporting Environment) Portal was lunched on Monday 5th December 2022 and is now available for submission of reports relating to adverse incidents for medical devices.

To submit via the new MORE portal, you will need to register for a MORE account.

Here is the link to the official page on Medical devices: guidance for manufacturers on vigilance with further information and instructions.

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Categories: News
Tags: UK
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