Authorized Representative Services
  • MDSS News & Events

    MDSS News & Views

UKCA marking!

The new UKCA marking is required after July 1, 2023.

Manufacturers should start acting now to ensure the deadline is met.

When affixing the UKCA marking, the manufacturer takes full responsibility for the product’s conformity with the requirements of the relevant legislation - Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). 

The cases in which the self-declaration of conformity can be used for UKCA marking are similar to those of the CE marking, such as for Class I devices and IVD general. The information required on the Declaration of Conformity is largely the same as what was required on an EU Declaration of Conformity. The manufacturer will need to list the relevant UK legislation (rather than EU legislation). 

For higher risk classes it requires a mandatory third-party conformity assessment and the conformity assessment has been carried out by a UK conformity assessment body

We recommend to contact your Notified Body as soon as possible and inquiry if they will be able to provide the service as a UK conformity assessment body. At the moment these are the recognized UK approved bodies.

Comment on youregulate.com...

Join our Seminar on the UKCA marking to learn more.

Categories: News

IVDR applicable for new Devices

Extension of one year for existing “OLD LEGACY PRODUCTS”  Manufacturers must act now to obtain this extra transition!!!!! (see below point 3)

 “NEW LEGACY PRODUCTS” with significant additional extension → Manufacturers must act now to issue new DOCs before May 2022 (see below point 4)


Numerous questions concerning the new Regulation (EU) 2022/112, which amends the IVD Regulation (EU)2017/746, are being raised. The amendment intends to ease the transition from the IVDD to the IVDR. It is pertinent for IVD manufacturers to fully understand these new opportunities to stay in business.   

The below provides a different approach outlining the new rules with further explanations. Please always refer to the actual regulation to identify the right solution for your devices and your company.

There are four types of products concerning the transition: 

1. Low risk class devices under the IVDD (commonly called risk class “other”), which are of risk class A (non-sterile) under the IVDR NO CHANGES!

The deadline applies in May 26, 2022 for this risk class. The lowest risk class products still must comply first. The obvious reason is that no notified body is involved and therefore those manufacturers are not affected by the shortage of notified bodies. The manufacturers can implement the requirements themselves and once in full compliance the Declaration of Conformity may be issued according to the IVDR.

2. Any Devices newly introduced after the deadline May 26, 2022, independent of the risk class, must comply to the IVDR →NO CHANGES!

New devices of all risk classes must fully comply with the IVDR upon market introduction after May 26, 2022.

The new extension applies to all LEGACY DEVICES – OLD and NEW! The term legacy device is not as such defined in the regulation. It is commonly being used for those devices, which are allowed to be compliant with the IVDD after the application date of the new regulation (IVDR) under certain specific conditions for a defined period. One condition is that no significant changes concerning the design and the intended purposes are permitted. It triggers immediately the IVDR for a legacy device (see above Number 2 → e.g. a new intended use equals a new device). In essence this is an extra transition for certain established devices. Originally it was foreseen for higher risk class products only, which are under the control of a notified body under the IVDD (let us call them OLD LEGACY DEVICES). An extension of one year is possible.

3. OLD LEGACY DEVICES: devices certified under the IVDD (Annex II and self-testing IVDs) → ONE YEAR EXTENSION POSSIBLE. The new deadline could be May 26, 2025. 


An additional year is being granted to those products if the certificate is still valid. The validity of the certificate must be checked now and manufacturers must receive the updated certificate before May 26, 2022, which outlines the validity until 2025.

There are two possibilities: 

  1. The certificate allows for an extension.  A certificate validity is limited to five year by the IVDD. To allow for a simple extension your certificate should permit for such an extension. This applies to all certificates issued after May 26, 2020.  If this is not the case, then   
  2. A new certificate must be issued. This may cause some other issues. 

A new certificate issued must be carefully checked in terms of the scope. For example, a scope which outlines the devices up to the SKU may limit you in terms of introducing minor updates allowed by the IVDR (non-significant changes). Certificates cannot be updated after the deadline. In any case this should be thoroughly discussed with your notified body. THEY MAY PROVIDE FOR OTHER SOLUTIONS. 

The additional extension is limited to only one year because those manufacturers already work with a notified body and are familiar with conformity assessment process.   

4. NEW LEGACY DEVICES: Devices not previously certified under the IVD (risk class other devices) and which must be certified under the IVDR  → BIGGEST CHANGES 

A new extension is now applied for a new set of devices (let us call them NEW LEGACY DEVICES), which are of the lowest risk class under the IVDD and are of a higher risk class under the IVDR and because of that they must involve a notified body under the IVDR - they are the NEW LEGACY DEVCIES. There are not enough notified bodies for those devices and therefore the IVDR regulation had to be updated accordingly. 


The good NEWS! The amending regulation (2022/112) for the IVDR 2017/746 provides a risk-based approach for a prolonged extension for the NEW LEGACY DEVICES. These devices must comply at a later point depending on their risk potential. This all makes sense.

Manufacturer should act now to review the DOC. Upon the deadline of May 26, 2022 the DOC is fixed and cannot be updated. It would be recommended to review the scope to allow for minor updates of the devices (non-significant).   

Comment on youregulate.com...

Please join our Seminar and learn on how to do that!

Categories: News

Swixit on hold?

On Sunday September 27, 2020, a referendum was held in Switzerland, which keeps the door open for a  Mutual Recognition Agreement (MRA) between Switzerland and the EU concerning medical devices. 

The initiative called for a restriction on the free movement of persons between the EU and Switzerland. A clear majority voted against it.  The free movement of persons is one of the pillars of the EU, alongside the free movement of goods. A vote against it would have promoted the Swixit process.  

 Read more...

Categories: News

Brexit

The never-ending story. Does it end now? 

According to the recent news, we have a high probability of a very hard Brexit.  

Read more...

Categories: News

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
  • UK Responsible Person

    6 Wilmslow Road, Rusholme, Manchester M14 5TP, UK

    +44 7898 375115

  • US Agent

    Chicago
    IL 60630
    USA

    +1 (312) 975-1694

  • Cosmetics Responsible Person

    Schiffgraben 41
    30175 Hannover
    Germany

    +49 511 6262 8630

  • CH-REP

    Laurenzenvorstadt 61
    5000 Aarau
    Switzerland

  • Importer

    Limmerstraße 15
    30451 Hannover
    Germany

    +49 511 62 62 86 30

MDSS GmbH

Schiffgraben 41
30175 Hannover
Germany

Share

Stay informed

We use cookies and other tracking technologies to improve your browsing experience on our website, to analyze our website traffic, and to understand where our visitors are coming from. By browsing our website, you consent to our use of cookies and other tracking technologies.