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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 immediatelySee here our feedback and give your own opinion to the Commission here.

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Categories: News

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 a certificate or a declaration of conformity issued before 26 May 2021, 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

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

EU MDR BRIDGE

Deadline/transition - further info!

What else happened last Friday, next to the proposed extension of the MDR Deadline for legacy products (see our Newsletter from Monday)?  

The MDCG 2022-18, a very special guidance, was published, intended to guide in particular authorities, to help manufacturer to bridge to the MDR. This is needed since the deadline extension will most likely have a cut-off date. 

The MDCG 2022-18 clarifies and tries to harmonize Article 97 on “Other non-compliance”.

What is clarified:

  • A missing certificate is just a non-compliance!
  • The allowance from one CA to market the products is valid for the whole EU.
  • Free Sales certificates may be issued.

What is harmonized:

  • Member states should apply the process and accept documents in a similar manner
  • Member states agree on a standard communication

Some of the rules, in particular the limitation to one year or to SMEs, cannot be found in the MDR. In any case, it may be wise, if not existential, for companies to go this route and if indeed the device is safe and this can be demonstrated objectively, then a member states may not have a choice but to allow the marketing of the products.

MDSS has already successfully supported several clients in navigating them through these complex procedures and enabling them to market the products despite facing the expiration of the MDD certificate and not being MDR certified yet. 

We are looking forward to supporting all our clients as EC REP!

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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

EU MDR deadline/transition!

Is Europe preventing the Chaos and getting back to Order with this extension proposal?

The outcome of last Friday's, December 9, 2022, EPSCO meeting was that, indeed, the transition period of legacy products is going to be extended!

  • Until 2027 for risk class IIb and III
  • Until 2028 for risk class IIa and class I up-classified

Additionally, there was the removal of the sell-off period. However, this might not help Manufacturers located outside the EU, since the Importer is the one placing the product on the market. Further clarifications may be needed from the Commission.

Among others, the extension was announced in this paper. The member states had a chance to express their views on the topic and there was, in fact, great support. If you are interested, you can watch here EU law making in progress. 

The details still need to be provided and the proposal must go through the legal process before implementation.

Unfortunately, details are yet to follow and the big question to be answered now is: from which date are legacy products being included? It could be that certificates which have expired are as well honored. However, there might be a cut-off date which does not include your certificate.

Therefore, the outline is to follow Article 97!

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Categories: News

MHRA update!

It is now official - twelve-month extension to the current standstill period on the future regulation of medical devices in the UK.

Here is the official communication.


Join our Seminar on Thursday and get your questions answered and all the latest updates!

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Categories: News

EUDAMED registration



1.  Obtain the Actor ID / SRN

The economic operator will obtain a unique Actor ID/SRN for each actor role. If the economic operator has multiple roles, separated registration requests are required in order to obtain a different and specific Actor ID/SRN for each actor role.

What is an Actor ID / SRN ?

The Actor ID/SRN (Single Registration Number) uniquely identifies every economic operator in EUDAMED. The Actor ID/SRN is issued once the relevant competent authority has validated the Actor registration request.

 If the economic operator has multiple roles, separated registration requests are required in order to obtain a different and specific Actor ID/SRN for each actor role. 


2.  Validation Process

  • The economic operator submits an actor registration request in EUDAMED.
  • For non-EU manufacturers, its authorised representative verifies the registration
    request before passing it to the national competent authority for assessment.

Keep in mind that information provided during the Actor registration has to match with the signed Mandate with the authorised representative.

  • The national competent authority issues the Actor ID/SRN (generated by EUDAMED)
    after approving the registration request.

EUDAMED notifies the Actor ID/SRN via email to the economic operator.

MDSS requires with the actor registration in Eudamed that the MDR Mandate is being executed with MDSS and that MDSS has received the Mandate according to the MDR.



Categories: News

Entry into force of the IvDO!

The new Ordinance on In Vitro Diagnostic Medical Devices (IvDO) has entered into force on May 26, 2022 and the Ordinance English version is now available!

Check your obligations and the deadlines for your products.


24/05/2022

IvDO adopted!

It is confirmed. Switzerland adopted the new Regulation on In-vitro Diagnostics (IvDO), which mainly refers to the IVDR.  

The provisional text in German language is available here. Now we need to wait for the final version to be published in the Swiss Federal Council website.  

Once it is published, check for yourself for your devices.


* based on the information from Swiss Medtech

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Categories: News

Training Programs

MDSS considers constant training of employees as a crucial pillar of good service. For this reason we provide training to build up the knowledge base needed for the implementation of the MDR. This is also recognized by the EU and via our local state of Lower Saxony MDSS was given a grant for its efforts. We are proud to display the poster and placate on our building to advertise these measures. It specifically states support for the external training done as Sales Manager. 

Sema Ketenci-Bär, responsible for our sales department completed this extensive training program. We congratulate our colleague Sema Ketenci-Bär for finishing the Sales Manager course and passing the the test successfully.

Categories: News

UKCA marking!

The new UKCA marking is required after July 1, 2023.

Manufacturers should start acting now to ensure the deadline is met.

When affixing the UKCA marking, the manufacturer takes full responsibility for the product’s conformity with the requirements of the relevant legislation - Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). 

The cases in which the self-declaration of conformity can be used for UKCA marking are similar to those of the CE marking, such as for Class I devices and IVD general. The information required on the Declaration of Conformity is largely the same as what was required on an EU Declaration of Conformity. The manufacturer will need to list the relevant UK legislation (rather than EU legislation). 

For higher risk classes it requires a mandatory third-party conformity assessment and the conformity assessment has been carried out by a UK conformity assessment body

We recommend to contact your Notified Body as soon as possible and inquiry if they will be able to provide the service as a UK conformity assessment body. At the moment these are the recognized UK approved bodies.

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Join our Seminar on the UKCA marking to learn more.

Categories: News

IVDR applicable for new Devices

Extension of one year for existing “OLD LEGACY PRODUCTS”  Manufacturers must act now to obtain this extra transition!!!!! (see below point 3)

 “NEW LEGACY PRODUCTS” with significant additional extension → Manufacturers must act now to issue new DOCs before May 2022 (see below point 4)


Numerous questions concerning the new Regulation (EU) 2022/112, which amends the IVD Regulation (EU)2017/746, are being raised. The amendment intends to ease the transition from the IVDD to the IVDR. It is pertinent for IVD manufacturers to fully understand these new opportunities to stay in business.   

The below provides a different approach outlining the new rules with further explanations. Please always refer to the actual regulation to identify the right solution for your devices and your company.

There are four types of products concerning the transition: 

1. Low risk class devices under the IVDD (commonly called risk class “other”), which are of risk class A (non-sterile) under the IVDR NO CHANGES!

The deadline applies in May 26, 2022 for this risk class. The lowest risk class products still must comply first. The obvious reason is that no notified body is involved and therefore those manufacturers are not affected by the shortage of notified bodies. The manufacturers can implement the requirements themselves and once in full compliance the Declaration of Conformity may be issued according to the IVDR.

2. Any Devices newly introduced after the deadline May 26, 2022, independent of the risk class, must comply to the IVDR →NO CHANGES!

New devices of all risk classes must fully comply with the IVDR upon market introduction after May 26, 2022.

The new extension applies to all LEGACY DEVICES – OLD and NEW! The term legacy device is not as such defined in the regulation. It is commonly being used for those devices, which are allowed to be compliant with the IVDD after the application date of the new regulation (IVDR) under certain specific conditions for a defined period. One condition is that no significant changes concerning the design and the intended purposes are permitted. It triggers immediately the IVDR for a legacy device (see above Number 2 → e.g. a new intended use equals a new device). In essence this is an extra transition for certain established devices. Originally it was foreseen for higher risk class products only, which are under the control of a notified body under the IVDD (let us call them OLD LEGACY DEVICES). An extension of one year is possible.

3. OLD LEGACY DEVICES: devices certified under the IVDD (Annex II and self-testing IVDs) → ONE YEAR EXTENSION POSSIBLE. The new deadline could be May 26, 2025. 


An additional year is being granted to those products if the certificate is still valid. The validity of the certificate must be checked now and manufacturers must receive the updated certificate before May 26, 2022, which outlines the validity until 2025.

There are two possibilities: 

  1. The certificate allows for an extension.  A certificate validity is limited to five year by the IVDD. To allow for a simple extension your certificate should permit for such an extension. This applies to all certificates issued after May 26, 2020.  If this is not the case, then   
  2. A new certificate must be issued. This may cause some other issues. 

A new certificate issued must be carefully checked in terms of the scope. For example, a scope which outlines the devices up to the SKU may limit you in terms of introducing minor updates allowed by the IVDR (non-significant changes). Certificates cannot be updated after the deadline. In any case this should be thoroughly discussed with your notified body. THEY MAY PROVIDE FOR OTHER SOLUTIONS. 

The additional extension is limited to only one year because those manufacturers already work with a notified body and are familiar with conformity assessment process.   

4. NEW LEGACY DEVICES: Devices not previously certified under the IVD (risk class other devices) and which must be certified under the IVDR  → BIGGEST CHANGES 

A new extension is now applied for a new set of devices (let us call them NEW LEGACY DEVICES), which are of the lowest risk class under the IVDD and are of a higher risk class under the IVDR and because of that they must involve a notified body under the IVDR - they are the NEW LEGACY DEVCIES. There are not enough notified bodies for those devices and therefore the IVDR regulation had to be updated accordingly. 


The good NEWS! The amending regulation (2022/112) for the IVDR 2017/746 provides a risk-based approach for a prolonged extension for the NEW LEGACY DEVICES. These devices must comply at a later point depending on their risk potential. This all makes sense.

Manufacturer should act now to review the DOC. Upon the deadline of May 26, 2022 the DOC is fixed and cannot be updated. It would be recommended to review the scope to allow for minor updates of the devices (non-significant).   

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Please join our Seminar and learn on how to do that!

Categories: News

Swixit on hold?

On Sunday September 27, 2020, a referendum was held in Switzerland, which keeps the door open for a  Mutual Recognition Agreement (MRA) between Switzerland and the EU concerning medical devices. 

The initiative called for a restriction on the free movement of persons between the EU and Switzerland. A clear majority voted against it.  The free movement of persons is one of the pillars of the EU, alongside the free movement of goods. A vote against it would have promoted the Swixit process.  

 Read more...

Categories: News

Brexit

The never-ending story. Does it end now? 

According to the recent news, we have a high probability of a very hard Brexit.  

Read more...

Categories: News
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