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There you will find all relevant information to enable your daily work in the regulatory field!
Contact us if you have any question.
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
CEN and CENELEC make European standards freely available relevant for the crisis. Standards are created by standard organizations who carefully draft those. It sometimes takes several years of negotiations until a standard sees the light and can be used.
The European Union (EU) in general calls out it its directives and regulations (EU laws) general essential safety and performance requirements. Different solutions by manufacturers for the compliance may be applied. Compliance with those requirements then will allow for the CE marking and the placing of the devices on the so called single European Market.
In order to further facilitate this approach technical solutions as well are needed to be harmonized and this is achieved in Europe with standards which, once published in the official Journal of the EU, may be used to show compliance with the general essential safety and performance requirements. Those standards are called harmonized standards and they play a pivotal role in the Europe. A so-called presumption of conformity is being achieved when complying with these important standards.
Making those harmonized standards freely available may allow new manufacturers normally not making medical devices or personal protective equipment to quickly adjust.
Here is the link to the press release of CEN and CENELEC.
And here you can find the corresponding press release of the European Commission.
On a regulatory level the EU allows important devices to be placed on the EU market without the CE mark relevant for the fighting of the COVID-19 crisis. Those are Products covered by Regulation (EU) 2016/425 on personal protective equipment (PPE) and medical devices covered by the Directive 93/42/EEC (MDD) or Regulation (EU) 2017/745 (MDR).
Certain PPE and medical devices are disparately needed to fight the Covid-19 crisis. The CE mark has to be put on those products in order to place them on the market in Europe. It may be noted that certain products may have to comply to both regulations since both have a different objective. Face mask or gloves protects the patient (medical device) and protect the user (PPE).
The PPE requirement for these types of product understandably are of the highest risk category and therefore may need to involve a notified body to achieve the CE mark. The medical devices are of a lower risk class and may be placed on the market and a notified body does not need to be involved.
With the Commission Recommendation (EU) 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat now allows the placing on the market of these products without the CE Mark. But only with a full evaluation (approval) of a market surveillance authority.
Please find the recommendation here.
This important initiative of the EU, allows others to produce these highly needed devices like for example the clothing industry in terms of the face masks.
On 25 March 2020, the Commission adopted three Implementing Decisions on harmonised standards which will allow manufacturers to place on the market devices that play a pivotal role in the current coronavirus pandemic:
Here is the publication on the Official Journal of the European Union.
More info about this harmonisation is also available in this press release.
We will comment based on the feedback and questions MDSS may receive.
The Covid-19 outbreak is rapidly changing lives and business practices worldwide. Increasingly stricter measures are being implemented to protect public health.
During these difficult times the safety and well-being of our families, friends and colleagues are our highest priority.
Authorised Representatives in the medical devices industry are committed to support the medical devices industry and the availability of health care products. However, we must comply also with any restrictions applied by the various governments and also implement our own Covid-19 crisis plans based on the further recommendation given, e.g. protection of employees at high-risk and working remotely, including quarantine and social distancing. It may even be necessary to temporarily suspend operations.
Currently the resources of the Authorised Representatives are stretched in implementing the final stages of compliance concerning devices in the risk class I under the new Medical Devices Regulations (MDR). Those devices must comply with the new regulations by the 26th of May 2020. As with every implementation just before any deadline, a spike of compliance activities occurs. The Authorised Representative plays a pivotal role under the new requirements of the MDR, for instance with the obligation to verify compliance documentation for Class I devices.
Many devices in risk class I produced outside the European Union are needed by the European health care systems to cope with the Covid-19 outbreak. Even if these products were previously compliant under the Medical Devices Directive (MDD), they will now have to be scrutinized by the Authorised Representatives in order to comply with the MDR.
We hope that you will understand when bottlenecks may occur in this process.
Please be aware that Authorised Representatives may have to prioritize the verification of products needed for this crisis.
Please contact your Authorised Representative directly for further information.
MDSS has business continuity plans in place to provide exceptional, uninterrupted service. Most of our employees are seamlessly performing their jobs remotely. We will always be here when you need us most, and you can count on us to continue providing the same high level of service.
Stay healthy and safe!
Products, which stay class I under the MDR, must be in full compliance by May 26 2020!
Conclusion: All risk class I devices (MDD/MDR) must comply by May 26. 2020!
This means the EC REP contract must be fully executed and the EC REP must have performed the tasks outlined in the Mandate for the risk class I devices by May 26. 2020! Otherwise the products cannot be sold in Europe.
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.
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.
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.
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.
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.
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:
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:
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.
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!
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.
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