M/565 COMMISSION IMPLEMENTING DECISION C(2020) 2532 of 15.5.2020 on a standardisation request to the European Committee for Standardization and the European Committee for Electrotechnical Standardization as regards medical devices in support of Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746 of the European Parliament and of the Council
In writing and set in stone with the publication on the Official Journal of the European Union.
On Friday, April 17, 2020, the European Parliament approved to delay by one year the EU Medical Device Regulation with 693 votes in favor, 1 against and 2 abstentions. A great support!
HOWEVER, the proposal now has to be approved by the member states and published in the Official Journal before taking effect. This should only be a formality.
The delay is due to the COVID-19 fight but it will be beneficial for others as well. Here is the European Parliament press release.
The 12 month delay is just a short period considering that the Importer will now request MDR compliant products. This special issue will be covered by our Webinar.
The European Commission adopted a proposal to postpone the implementation of the EU Medical Device Regulation (EU) 2017/745 on medical devices as regards the dates of application of certain of its provisions.
Here is the full proposal.
Medtech Europe asked the Commission to delay the MDR. Here is the Press release.
German association supports the initiative and it seems that the German Ministry of Health is responding to this positively.
Peter Liese MEP who was one of the lead Parliament member for the implementation for the MDR and IVDR is communicating that he believes it is necessary that the MDR must be postponed. Here is his twitter post.
MDSS certainly supports such initiative for the sake of the patients affected by the current situation and our clients during this difficult times. A delay will release resources to cope with the current situation as well important products which may have been banned due to the MDR requirements can still be placed on the market.
Here is the College meeting of 25/03/2020 video
The notified body (NB) designation is moving along. Congratulation to NSAI. We have to note the scope NSAI shows as one of the smaller notified bodies. It includes active implantable medical devices. Well Done!
However, we like to congratulate all NBs who have made it to the Nando Website as of today.
Early this year it was communicated that 3 more notified bodies are in the pipeline. After DNV GL Presafe and NSAI we are waiting for the third one to be published. We may not see a big wave and we may see the majority of NBs notified after May 26 – the application date of the MDR!
This means that the additional transition as provided by MDR Article 120 (3) is the norm and not the exception.
What else is there to note:
1. BSI UK is still listed and will stay on the list because the Brexit deal provides for business is as usual - at least until the end of this year (see MDSS N&V here).
2. The notified bodies must train all the auditors and experts to the MDR requirements. They must be reviewed in regards to their qualification and experience (see MDR Annex VII). This is a lot more cumbersome as with the directive. Clients reported that their auditor stated that they would not come back due to their lack of qualification under the MDR. I guess someone may ask the question whether those were actually qualified under the MDD!
3. Even before quoting the service the NB shall conduct a preliminary verification that the product is covered by the MDR and the classification (Annex VII 4.2 d).
4. Article 50 requires the Notified Body to publish the list of their standard fees. This will be interesting to see whether you will be able to estimate the final cost and Annex VII requires to have all costs fixed in procedures for the different activities. How can a notified body know what resources it takes if the service was never applied! This only can mean high estimates of fees in the beginning and we only can hope that some of the prices communicated may drop in the near future upon the actual experience.
There is a lot more to say. Be aware of the NB requirement in MDR Annex VII to be prepared for the new NB process.
The below is a screenshot from the Nando website.
Warning: No additional transition for risk class I products. Products who are risk class I and stay of risk class I must fully comply to the MDR by May 2020.
Please consider the MDCG guidance Guidance Notes for Manufacturers of Class I Medical Devices cover.pdf - December 2019. It was recently published and is great outline of what needs to be done specifically for risk class I products (see also News & Views 2019.12.19). We guess we can call this THE EIGHT STEPS TO CLASS I CE MARK.
Indeed it does extract the important aspects and should get you in compliance quickly.
The MDR deadline for Manufacturers of risk class I products is approaching. The days until May 26, 2020 are numbered!
It is fundamental that class I Manufacturers prioritize their MDR compliance in order to ensure a smooth transition to the MDR and avoid any market disruption by May 2020.
The transition period has started in 2017. Manufacturers must update the declaration of conformity to reflect the compliance to the MDR. This does not include only an update of the technical documentation but also the requirements of Article 10 to meet the new MDR requirements.
CONTACT NOW your MDSS team to get your products ready to market by May 2020!!!
The existing MDD Authorized Representative contract will no longer be sufficient for the transition to the new regulation. The appointment of the Authorized Representative under the MDR is a mandatory requirement to achieve compliance by May 26, 2020. In order to act as your EC REP, the regulation requires that the Manufacturer provides an official Mandate to the EC REP. Such a mandate shall be in writing and agreed by the EC REP. The mandate shall contain a minimum set of tasks. The new MDSS MDR EC REP contract is the basis for such a mandate. Clients should submit their MDR transition plans and consider MDSS resources to perform the tasks required under the MDR mandate.
MDSS has implemented a special plan for its clients. Any remuneration fees still not used on the MDD contract will apply to the MDR Mandate.
Please contact your Account Administrator at MDSS!
- The European Medical Device Nomenclature (EMDN) - the nomenclature of use in EUDAMED!
The European Medical Device Nomenclature (EMDN) will be the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database.
- The CND Nomenclature - background and general principles.
The purpose of this document is to provide information regarding the basic principles and the structure of the Italian “Classificazione Nazionale Dispositivi medici” (CND).
MedTech Europe issued in December an update on the List of Symbols.pdf, which may be useful to consider in particular for the transition to the MDR. For example it provides the indication that a device is a medical device.
As always, as long they are not harmonized, they must be repeated in the IFU including the description. The nice feature here is that the translations are already provided in case you will have to translate the IFU.
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):
‘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 …’,
‘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!
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.
Plan with your EC REP to get your products ready to market by May 2020. The deadline is approaching quickly and EC REPs resources need to be allocated. Clients submitted their MDR transition plans considering as well the MDSS resources to perform the tasks required under the MDR. Certainly the new MDR contract is the basis for starting this process. The EC REP MDD contract is not sufficient for the MDR compliance. The MDR disappointed some clients who believed a SIMPLE UPDATE will do it.
Please contact your account administrator at MDSS who will take care of you!
MDCG 2019-15 - Guidance Notes for manufacturers of class I Medical Devices was published last Tuesday, the 17th of December.
And other guidance have been published which are also important.
You may monitor with your quality system this website of the European Union. It seems that all guidance’s are being published here first. The docsroom.
Most certainly the overall EU website for medical devices provides further information:
Here you may subscribe to newsletter to be informed of changes. It is our impression that it does not always work or you receive a newsletter rather late.
The following important vigilance documents have been published on the European website:
The new Manufacturer’s Incident Report (MIR) Form has been updated and a copy of the latest version (version 7.2) and detailed guidance/ help text that may assist in completing the form are available on the Commission website.
Based on the additional guidance on the MEDDEV 2.12/1 rev.8 section 4, the current version of the MIR Form included a number of new concepts:
The updated version of the MIR Form V 7.2 will become mandatory from January 2020.
However, if you are a manufacturer and have already adapted your IT system to version 7.1, you may use this version until the end of March 2020.
For more detailed information, please do not hesitate to contact your MDSS team!
Last Wednesday, the 4th of December 2019, the European Commission released new documents related to the technical specifications for unique device identifiers (UDIs).
In Europe the regulatory community follows closely the latest MDR developments. The rumors, that certain class I products may receive a significant extension, was substantiated last week with the proposal of a second corrigendum. It still may need to go through the Parliament but it passed another hurdle. The regulatory community got all excited and information on social media exploded (we are on LinkedIn - please feel free to connect!).
The Parliament Committee on the Environment, Public Health and Food Safety voted in favor of the corrigendum. Here for the record is the vote! Go to 11:33:30 to see the vote and also the serious comment made.
This provides a great relief for risk class I products that will need the involvement of a Notified Body under the MDR. The products may be placed on the market until May 2024. Please note, certain conditions apply.
Final voting has to go via the Parliament. Let us hope for the best!
Possibly 4 more years for class I products which must be certified under the MDR (e.g. reusable surgical instruments (Ir), software or substances). The second corrigendum has been published and it is up for final approval. Everything is possible.
Let’s hope for the best!
As it seems the Authority of Denmark is concerned with the MDR and provides guidance on the new Regulation.
Obtain a detailed guidance for the upcoming changes. As well as Guidance about requirements and processes regarding applications for clinical investigations in regard to specific products as well as general regulations about CE marking. The Danish Medicines Agency offers 1 hour meeting regarding regulatory advice in English.
Schedule a meeting with the Danish Competent Authority free of charge!
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.
Published September 3.
We will review this new update and check whether it effects our Responsible Person (RP) contract and update accordingly if needed.
The Medical Devices (Amendment etc.) (EU Exit) regulations 2019
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:
Now we have to distinguish between two product groups.
Products which are certified with a NB:
For class I products:
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:
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.
April, 2019 update
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