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  • MDSS News & Events

    MDSS News & Views

Q & A - new Manufacturer Incident Report (MIR) Form

In December 2018, a new Manufacturer Incident Reporting (MIR) form and related documentation have been published at the European Commission website. The form introduced novel information requirements such as use of IMDRF adverse event terms and codes or trending data based on relevant similar incidents.


Read more...

Categories: News

Exciting developments regarding Harmonized Standards!

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

Read more...

Categories: News

Revised list of IMDRF codes also includes Annex G (component codes)

The International Medical Device Regulatory Forum (IMDRF) published the last piece of a code system which may be used worldwide for various applications. In Europe the code system is needed for notifying incidents with the Competent Authorities. The manufacturer Incident Report (MIR) is the tool for that and requires these codes in various section of this form.

Read more...

Categories: News

New MDCG guidance documents!

The European Commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations. Legally non-binding guidance documents, adopted by the medical device coordination group (MDCG) in accordance with Article 105 of Regulation 745/2017, pursue the objective of ensuring uniform application of the relevant provisions of the regulations within the EU.

Read more...

Categories: News

COVID-19 info!

  • European Commission Comments for Consideration on COVID-19 In Vitro Diagnostic Tests and Their Performance 
  • Commission Working Document - Current Performance of COVID-19 Test Methods and Devices and Proposed Performance Criteria    
  • An overview of the rapid test situation for COVID-19 diagnosis on the EU/EEA    
  • Guidance on devices in the COVID-19 context

Read more...

Categories: News

MDR Delay!

2020.04.24

In writing and set in stone with the publication on the Official Journal of the European Union.

Here is the publication.


2020.04.20

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.


2020.04.03

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.


2020.03.25

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

Categories: News

Standards free of charge!

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.



What else:  

  • Certainly, you need to know where you can get those standards. They can be obtained with the national standard originations here.

Categories: News

No CE marking needed!

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.  


What else:

  • Notified Bodies (NB) under Regulation (EU) 2016/425 should prioritize the assessment if they apply the CE marking.
  • Other technical solutions like for example the WHO recommendations may also be considered by the NBs.
  • For medical devices the reference to the Article 11 (3) MDD and Article 59 MDR is being made for member states to allow for derogation form the conformity assessment. Should a product not fully comply the Authority may apply this compliance route.
  • Certainly, only for the duration of this crisis.
  • Only for the healthcare workers and not for the general public.



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.  



In addition, important standards have been harmonized (see here) and certain standards are now freely available for those manufacturers (see here).

Categories: News

New and current standards have been harmonized with the current directives!

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.

Categories: News

Statement on Covid-19

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!

Categories: News

Warning - For risk class I devices!

Products, which stay class I under the MDR, must be in full compliance by May 26 2020!



  1. MDSS concern: Some clients seem to be under the impression that there was an extension given until May 2024 due to the MDR second corrigendum. This is not true.


  2. MDSS concern: Clients who have class I devices and higher risk class devices were also under the impression that their risk class I devices are also covered by the EC certificate for the higher risk class devices. This is not true. Please check in particular the accessories.


  3. MDSS concern: Clients who mainly have In Vitro Diagnostic Medical Devices, were under the impression that their medical devices as well fall under the application date of the IVD Regulation. This is not true.



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.

Categories: news

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
MDSS GmbH

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30175 Hannover
Germany

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