MDSS News & Views

• 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...

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.

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).

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:

• for MDD 93:42:EEC.pdf: 264 harmonised standards listed, 16 new/revised, 12 withdrawn
• for AIMDD 90:385:EEC.pdf: 46 harmonised standards listed, 5 new/revised, 4 withdrawn
• for IVDMDD 98:79:EC.pdf: 41 harmonised standards listed, 4 new/revised, 3 withdrawn

Here is the publication on the Official Journal of the European Union.

More info about this harmonisation is also available in this press release.

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!