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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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Categories: News

Second Corrigendum to the MDR and IVDR

This update gives certain Class I manufacturer a break.  



On December 27 the second corrigendum was published in the official Journal of the EU. This update was indeed needed, otherwise with the lack of notified bodies (NB) the European health care system would have fallen apart. This update is a great relief for everyone. Certainly in particular for manufacturers who are directly affected by this. Here is the wording which does the magic:


On page  89, Article 120(3):
for:
‘3.   By way of derogation from Article  5 of this Regulation, a device with a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and which is valid by virtue of paragraph  2 of this Article may only be placed on the market or put into service provided that from the date of application of this Regulation it continues …’,
read:
‘3.   By way of derogation from Article  5 of this Regulation, a device which is a class I device pursuant to Directive 93/42/EEC, for which the declaration of conformity was drawn up prior to 26 May 2020 and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, or which has a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and that is valid by virtue of paragraph  2 of this Article, may be placed on the market or put into service until 26 May 2024, provided that from 26 May 2020 it continues …’.

In other words: All products of risk class I according to the MDD, which will have to be reclassified under the MDR to higher risk class and all risk class I reusable surgical instruments which stay class I but will need to involve a NB according to the MDR can be placed on the market until 2024 with complying to the MDD. A certification is not needed until then! However, please keep in mind that certain aspects of the MDR must be implemented. For example the vigilance according to the MDR. Please refer to the details of the MDR Article 120!



WARNING:
All other risk class I products must comply to the MDR by May 2020!! How funny!  The products with the lowest risk portfolio need to comply to the most stringent regulation first!! This update should have allowed those products as well for the extension. Laws sometimes take an interesting direction.


Just one detail to this corrigendum. It actually changes the regulation and this should not be possible via a corrigendum. A corrigendum normally crosses the ts and adds the dots.  There are other minor changes, which we have not reviewed. All the changes need to be assessed by the manufacturer to verify that this does not have an impact on you. The first corrigendum as well provided for some surprises and in fact impacted the requirements significantly. Someone could argue that those were not only Ts and dots.



Certainly as soon the consolidated version is available it is recommended to update your library.

Corrigendum to Regulation (EU) 2017:745.pdf

Corrigendum to Regulation (EU) 2017:746.pdf

Categories: News

New information on expert panels published

The MDR/IVDR envisages expert panels, who shall assist the European Commission, the Medical Devices Coordination Group, Member States, Notified Bodies and manufacturers in technical, scientific and clinical aspects.
Now a decision of the European Commission (Implementing Decision (EU) 2019/1396) has been published which describes the designation and functioning of these expert panels in more detail.
There will be 11 expert panels covering different medical areas where a need for expertise is seen. In addition, there will be another expert panel dealing with additional tasks (MDR Annex IX, section 5.1 letter c). The Medical Devices Coordination Group appoints the advisors for a term of 3 years and paid €450 per each full working day. Their independence, impartiality and objectivity should not be affected, which should be verified by a written declaration of interests. Among other things, the names of the advisors appointed, the common rules of procedure and the opinions, views and positions should be made publicly accessible in order to represent a transparent working method.
Article 54 of the MDR states in Section 1 that Notified Bodies must consult a panel of experts for special high risk products when carrying out a conformity assessment. Conversely, this means that these expert panels must already be in place for a manufacturer to complete the clinical evaluation of his high-risk product. Therefore, it is currently not possible to certify such products according to MDR and thus put them on the market. If no expert panels have been appointed by May 2020, it is expected that the concerned products will initially be certified without corresponding expertise.

Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices (2019/C 323/05) is open!

Categories: News

Another update on UK guidance!

Published September 3.


We will review this new update and check whether it effects our Responsible Person (RP) contract and update accordingly if needed.  


Please review for yourself.



Clarification is definitely needed because the proposed law is not clear on a very specific concern and hopefully the new guidance will provide the clarification.



STATUTORY INSTRUMENTS
2019 No. 791
EXITING THE EUROPEAN UNION
Consumer Protection


The Medical Devices (Amendment etc.) (EU Exit) regulations 2019

Categories: News

It`s about time…

It is about time to start YOUR MDR/IVDR project. Even though the whole world is lamenting about the new Medical Device Regulation (MDR) and In-vitro Diagnostic Medical Device Regulation (IVDR), it will not help. The deadline will (most likely) not be moved, and being late will exclude your products from the whole EU market. Should the Member States and the Parliament indeed come to the conclusion that moving the deadline is a sensible thing to do, it may not apply for all products, and it would not hurt your business to be the frontrunner setting the stage for selling your products with being MDR compliant.




In this issue of News and Views, we will focus on the MDR, but it applies similarly to IVD products, with different timelines.


The timeline in brief:



  1. The new regulation is enforced since 2017, and in some instances can be fully applied.

  2. The new regulation must be applied in May 2020.

  3. The MDD will cease to exist.


Now we have to distinguish between two product groups.

  1. Products which are associated with a notified body (NB) and  certified with a NB. These are products of risk class IIa, IIb, III, and products of risk class I which are sterile or have a measuring function.
  2. Risk class I products.


Products which are certified with a NB:

  1. The MDR provides that those products may be ‘placed on the market’ until 2024 with a valid MDD certificate and certain MDR provisions.
  2. Extensions of MDD certificates are still issued by NB.  Should your certificate expire somewhere around 2022, an extension may be indicated. The extension, or for that matter any certificate according to the MDD, must be issued by the NB by May 2020.
  3. The NB will not be able to issue a new certificate after the application date. The products are covered by those certificates as long there is no change of intended use or a significant design change.


For class I products:

  1. They must comply with the regulation by May 2020.

MDSS is concerned with the implementation - the lack of resources in the industry and not just with the notified bodies, and other very specific implementing aspects. However, we are particularly worried in regards to:

  1. Products of risk class I.
  2. Products, which were previously not covered by the MDD, but now need to be certified due to the extended scope of the MDR.
  3. Products of previously class I, which now need to be certified by May 2020. Those are:

a. Risk class I reusable instruments.

b. A lot of software due to the new software classification rule.

c... any other product being class I under the MDD and now of a higher risk class (possibly substances and products including nanomaterial).


Those products under point 2 and 3 need to be certified and will face the NB shortage.  Our advice is: GET IN CONTACT WITH A NB OR WITH YOUR NB TO DISCUSS THE MDR CERTIFICATION PLAN…NOW!


A great concern for us are the manufacturers who only have risk class I products in their portfolio. They have not been exposed to a mandatory quality system or any third party review.  In addition, in their home countries, not much control was applied either (i.e. in the USA they may also be FDA exempt). The reason is simply that they do not pose a lot of risk.

The particular concern is that those risk class I products may not be able to comply on time, due to the extensive technical file and quality system requirements that apply for these risk class I products just as they apply for the highest risk class products. Article 10 outlines those requirements, and that article does not distinguish between risk classes!!!  Act now!



The lowest risk class products need to fully comply earlier than the highest risk class products!  ‘Great job, lawmaker!’ - a patient may say when he has to wait for his low risk class product due to administrative delay.

Categories: News

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March, 2019 

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February, 2019 - Second Update

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February, 2019 - Update

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February, 2019

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January, 2019 - Second update 


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January, 2019 - Update


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January, 2019


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