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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

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

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

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

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
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