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  • MDSS News & Events

    MDSS News & Views

Notified body number 11!

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.

Categories: News

Brexit Deal! Business as usual! Until when??

There are no change in business in the UK with the current Brexit Deal in place (Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community). Now the UK and the EU have the chance to agree on a trade agreement by December 31! Whether this will happen remains to be seen. Therefore, a hard Brexit is still a possible scenario and may occur on December 31. Until then it means business as usual with the UK.



We shall revisit this issue in due time because we are expecting a specific Medical Devices law for the UK shortly in order to prepare for all possible scenarios.

Here is the link to the MDSS News & Views Brexit history.

Categories: News

Grace Period offered for products who lose the notified body without fault!

Guidance was always in place in the EU for a Grace Period (GP). However, it is always up to the member states (MS) to follow a guidance. The MHRA has applied GPs but commits itself now with a solid process. Other countries have given GPs. Among them Germany, Switzerland, etc.


MDSS as the EC REP has applied on behalf of a client with its Competent Authority (CA). This allowed the client to sell his products without a NB certificate for a defined period. For manufacturers outside the EU it is important to know that the relevant authority is the authority of the EC REP - not the authority of the NB. It is not a trivial process and requires some negotiation skills!


With the conditions, it is an individual process, which also takes resources away from the MDR implementation. The good news is that you will be able to sell the product EU wide.


Contrary to this, article 59 MDR or article 11 (13) MDD allows MS to permit the selling restricted to their territory.


The big questions is what happens in terms of the Brexit.  The MHRA GP may only last until the end of 2020 if there is not a trade agreement covering this aspect.  

Here the MHRA reference.

Categories: News

Agenda of the MDCG and the MDCG subgroups has been released!

The MDCG has been created according to Article 103 and the subgroups were implemented in 2019. The task are defined in Article 105 (see below).  Most likely we will see an increase of new documents and hopefully new notified bodies after each MDCG meeting.  





Article 103 Medical Devcie Coordinating Group.
1. A Medical Device Coordination Group (‘MDCG’) is hereby established.



2. Each Member State shall appoint to the MDCG, for a three-year term which may be renewed, one member and one alternate each with expertise …



The members of the MDCG shall be chosen for their competence and experience …
The alternates shall represent and vote for the members in their absence.
3. The MDCG shall meet at regular intervals …
4. The MDCG shall use its best endeavors to reach consensus. …
5. The MDCG shall be chaired by a representative of the Commission. …
6. The MDCG may invite, on a case-by-case basis, experts and other third parties to attend meetings or provide written contributions.
7. The MDCG may establish standing or temporary sub-groups. Where appropriate, organisations representing the interests … in the capacity of observers.
8. The MDCG shall establish its rules of procedure which shall, in particular, lay down procedures for the following:
— the adoption of opinions or recommendations or other positions, including in cases of urgency;
— the delegation of tasks to reporting and co-reporting members;
— the implementation of Article 107 regarding conflict of interests;
— the functioning of sub-groups.
14. The MDCG shall have the tasks laid down in Article 105 of this Regulation and Article 99 of Regulation





Article 105 - Tasks of the MDCG
Under this Regulation, the MDCG shall have the following tasks:
(a) to contribute to the assessment of applicant conformity assessment bodies and notified bodies pursuant to the provisions set out in Chapter IV;
(b) to advise the Commission, at its request, in matters concerning the coordination group of notified bodies as established pursuant to Article 49;
(c) to contribute to the development of guidance …
(d) to contribute to the continuous monitoring of technical progress …
(e) to contribute to the development of device standards, of CS and of scientific guidelines, …
(f) to assist the competent authorities of the Member States in their coordination activities …
(g) to provide advice, either on its own initiative or at request of the Commission, …
(h) to contribute to harmonised administrative practice with regard to devices in the Member States.

Categories: News

For risk class I manufacturer!

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.

Categories: News

MDR deadline for risk class I Manufacturers – Ready to appoint MDSS as your MDR EC REP?

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!

Categories: News

The UK never ending story comes to an end!

We published a Brexit News & Views beginning of October for our clients to react, if needed, should a hard Brexit occur, which was on the horizon at that time.



Since then the core message has not changed. The importer in the UK is the UK responsible person (UK RP) by definition. Given the current draft regulation it is NOT foreseen to appoint an independent UK RP. As it seems the MHRA is aware of this difficult situation and communicated with some industry associations that they were indeed not very happy about it. Their guidance still has a few inconsistencies and does not necessarily reflect the proposed law. Also, the law has some inconsistencies and in some instances does not make sense.



What has changed since our last News & Views regarding Brexit:


  1. The UK will leave on January 31, 2020 the EU and this will be done in a somewhat orderly manner (!?) with a withdrawal agreement.

  2. Our current understanding of orderly means a transition period is in place until December 31, 2020. This transition means that all EU rules and regulations will continue to apply, but the UK will be allowed to install their own laws. The Medical Device law is expected to be implemented in due time (March?!).

  3. The timeline outlined in the above News & Views, which are derived from MHRA guidance may no longer apply.

  4. The UK and the EU are supposed to reach a trade agreement by December 31, 2020.
    However, that is very unlikely and a delayed hard Brexit may still be possible.

  5. In June, the UK may ask for an extension of this transition beyond 2020 to complete the trade negotiation. However, the UK has already determined not to seek an extension.

  6. The proposal for an agreement must be in place by November to get it presented to the European Parliament in order to be ratified by the end of December.


Having stated the above, what needs to be done

It is important to review and maybe adjust the UK distribution. Anyone who receives your product in the UK, whether directly from a manufacturer or from any of the remaining EU countries is the  importer and can only import if he also takes on the requirements of the UK RP. There are a number of consequences:

  1. It may be needed to organize the UK distribution differently. For instance, it may be beneficial to have only one single distributor, who is the importer/UK RP, you can rely on.
  2. A solid agreement must support that role (required anyway for the importer).  
  3. MDSS may be installed for record keeping etc. However, this can only be done if the importer/UK RP allows it. A three way agreement should be in place.


From our UK clients we hear that the MHRA is trying to give advice to the lawmaker to change the proposed law in order to allow for an independent UK RP. However, we have checked and there is no update - yet.  


It is currently difficult to recommend a clear solution for the UK RP since the law is not finalized. Any agreement we would sign today most likely will have to be adjusted. Should there be the possibility of an independent UK RP then in that case a contract with MDSS is ready except for the any last minute changes.


In any case should December 31, 2020 become the deadline – again for a hard Brexit, then we recommend to stock products in the UK since in such an instance, trade will be significantly disrupted for a few months due the implementation of customs and border control.

Categories: News

Use of Symbols to Indicate Compliance with the MDR!

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.

Categories: News

New documents published by the Commission!

- 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).

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

MDR Transition!

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!

Categories: News

New Guidance published by the Commission!

The  two  new  Regulations  on  medical  devices  745/2017 (MDR) and  746/2017  (IVDR)(hereafter called the Medical DevicesRegulations) have been adopted and entered into force on 25 May 2017. The two Regulations, which are to replace three EU Directives, apply progressively until May 2020 for medical devices and May 2022 for in vitro diagnostic medical devices. Among the many novelties introduced, the two  Regulations enhance the focus of legislators on ensuring that devices placed on the EU market are fit for the new technological challenges linked to cybersecurity risks. In this respect, the new texts lay down certain new essential safety requirements for all  medical devices that incorporate electronic programmable systems and software that  are medical devices in themselves. They require manufacturers to develop and manufacture their products in accordance with the state of the art taking into account the principles of risk management, including information security, as well as to set out  minimum requirements concerning IT security measures, including protection against unauthorised access.

Read the compete document here. Please leave your comment/opinion below whether the document helpful for your MDR endeavor.

Categories: News

IMPORTANT, Important … Guidance for class I manufacturer!

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.

Categories: News

New Vigilance documents published on the European Commission website!

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 information is presented in a new structure.
  • Introduces international IMDRF coding/ terminology.
  • Introduces a definition of similar incidents and requires similar incidents trend data in a tabular format.
  • In preparation for the future EU MDR it also introduces (not mandatory yet):
    • the concept of SRN which will be utilized greatly in the future under the new regulations.
    • the use of UDI.


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!

Categories: News

European Commission offers Guidance on UDIs!

Last Wednesday, the 4th of December 2019, the European Commission released new documents related to the technical specifications for unique device identifiers (UDIs).

Categories: News

Total excitement on social media because of MDR Corrigendum!

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!



28-11-2019

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!

Second Corrigendum to the MDR

Categories: News

NO INDEPENDENT UK RESPONSIBLE PERSON (RP) POSSIBLE!!!


Brexit and Medical Devices

UK RESPONSIBLE PERSON = IMPORTER



What we already evaluated was strongly confirmed by a representative of the UK MHRA.  

And more importantly it was stated that no independent UK RP is possible.

Please see the latest UK law here to verify this for yourself. In order to come to that conclusion, someone should not only read the requirements for the UK RP (schedule 77). In particular, the definitions for importer, UK RP and the definition for placing products on the market are needed. Then by nature the importer is placing products from a third country on the UK market, and in Schedule 95 states: “… the person placing products on the market is to be regarded as the UK responsible person…”


It was indeed intended that the importer is the UK RP, without leaving the possibility for an independent service provider to take over this role.


This will not only change the regulatory landscape significantly, but more importantly, the overall business approach to selling products in the UK needs to be thoroughly reviewed.  


For example, the importer (your distributor, your precious customer) is now the UK RP and shall act on your behalf, with you being the manufacturer. However, the interest of a distributor may NOT coincide with the interest of the manufacturer. It starts already with the pricing, and how often was it necessary to change the distributor because you were not happy with their performance or demands?


It was clearly indicated that the manufacturer should act in order to prepare for this Brexit situation, but it was confirmed that the time line  for implementing will be granted (4, 8 and 12 month).


A more thorough evaluation will follow shortly, and there is only one really safe solution to secure the business. However, these are not only regulatory decisions any longer. This is now an overall business aspect. This means other departments of the company must be informed and should participate in the discussion - NOW.


Please contact MDSS for further details and the possible solution on this scenario. Our office in the UK could support your solution.  


Brexit scenarios:

  1. Brexit without a deal on October 31, 2019.

  2. Further extension for a few weeks or until January 2020 and then Brexit without a deal.

  3. Further extension with a deal. Transition until December 31, 2020 and then:

a. No agreement with the EU

b. Agreement with the EU and then:

i. Existing law as referenced above (only trade agreement but no Mutual recognition agreement (MRA) of approvals)

ii.New law and MRA.


And certainly, anything else may as well be possible.  


Categories: News

Guidance on software classification & other documents

The European Commission indeed works hard to provide further clarification on a number of aspects. Documents are now being issued frequently. It is great that long awaited clarification is being provided! However, stakeholder criticism is that some of the MDCG documents not only clarify aspects, but rather restate the requirements.  Another fear is, that additional requirements are being introduced with the clarification instead of providing just the needed clarifications. These two aspects may become obvious when you would apply them. We certainly would appreciate feedback regarding this matter.


In any case, those documents, if they apply to your products or system, should be considered. For example the new software guidance is very important to support your classification for your software. That document was published last Friday 2019.10.11.


Here is the list of documents for you to consider:

  • Software - First publication: 2019.10.11
  • Transitional provisions on MDD/IVD certificates - First publication: 2019.10.04
  • Call for expression of interest for expert panels - First publication: 2019.09.30
  • Manufacturer Incident Report (MIR) Form - Last update: 2019.09.30
  • Guidance on the vigilance system - First publication: 2019.09.26
  • Summary of safety and clinical performance - Last update: 2019.09.27
  • Unique Device Identification (UDI) System -  Last update: 2019.08.20


There are more documents to consider and the complete list can be found here.
It is the so called docs room which was offline for quite some time. Now, it is back.

In the past we have recommended to check here for updates but it seems that the docs room is quicker in publishing.

Categories: News

Free of charge MDR Authority meeting!

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!

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
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