MDSSAR News & Events

2023-03-03T00:00:00+01:00

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

2023-02-23T00:00:00+01:00

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the manufacturer, while the NB & Certificates module lets you register refused certificates, refused applications, and withdrawn applications of type product.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

2023-02-15T00:00:00+01:00

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

2023-01-26T00:00:00+01:00

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

2023-01-25T00:00:00+01:00

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

2023-01-16T00:00:00+01:00

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.

Comment on youregulate...

Categories: News

Tags: European Commission MDR IVDR

2023-01-12T00:00:00+01:00

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!

Comment on youregulate...

Categories: News

Tags: European Commission MDR IVDR

2022-11-15T00:00:00+01:00

Notified Bodies survey on Certifications and Applications under the MDR and IVDR

Check out the results of the Notified Bodies survey on certifications and applications under the MDR and IVDR published by the European Commission.

Check out the PDF file: md_nb_survey_certifications_applications_en-1.pdf

More information can be found here: https://lnkd.in/ehVE5svJ

Categories: News

Tags: Notified Body MDR IVDR

2022-10-11T00:00:00+02:00

Joint implementation and preparedness plan for IVDR

New document from the European Commission on Joint implementation and preparedness plan for IVDR!

"The Plan will serve as a living document to monitor their implementation"

It will also help to set priorities...

Here you can find the complete document: md_joint-impl-plan_en.pdf

Categories: News

Tags: IVDR

2022-03-15T00:00:00+01:00

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:

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
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

Tags: IVDR

2020-01-15T01:02:26+01:00

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

Tags: MDR IVDR Corrigendum

2019-10-03T00:00:00+02:00

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

Tags: MDR IVDR expert panels MDCG

2019-09-04T17:14:01+02:00

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

Tags: mdr IVDR Brexit MHRA

2019-09-02T01:00:00+02:00

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:

The new regulation is enforced since 2017, and in some instances can be fully applied.
The new regulation must be applied in May 2020.
The MDD will cease to exist.

Now we have to distinguish between two product groups.

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.
Risk class I products.

Products which are certified with a NB:

The MDR provides that those products may be ‘placed on the market’ until 2024 with a valid MDD certificate and certain MDR provisions.
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.
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:

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:

Products of risk class I.
Products, which were previously not covered by the MDD, but now need to be certified due to the extended scope of the MDR.
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

Tags: mdr IVDR Brexit

2019-04-01T00:00:00+02:00