Overview of CE Certification in 2016

Team NB, The European Association of Notified Bodies, released a summary of the Medical Device Sector survey. It gives insight into the number and types of CE and ISO certificates issued or withdrawn for Medical Devices, In-Vitro Diagnostic Devices and Active Implantable Medical Devices in 2016. Team NB assembles 22 European Notified Bodies, such as (among others): TUV, SGS or BSI.

Decrease in number of CE issued

In 2016 Notified Bodies issued 19.763 valid CE certificates. The number of certificates granted keeps decreasing since 2014. It declined by 13%: from 22.487 in 2014 to 19.763. The record low result was noted in 2010: 13.889 (30% fewer certificates issued than in 2016).

The vast majority of devices affixing CE mark are classified as medical devices (91%). IVDs represent only 7% of the market and AIMDD 2%. The majority of CE certificates were issued for companies located outside of Europe (68% vs. 32% for the EU businesses).

Notified Bodies gave out 4.098 new CE certificates in 2016 (meaning the ones awarded to the Manufacturer for the very first time). It is one of the lowest results since 2010 – the number has slightly decreased compared to 2015 (when 4.480 new CE were issued). The aforementioned data clearly shows that it becomes increasingly hard to obtain a new CE mark for medical devices and to find a Notified Body to work with.

All-time record for number of CE withdrawn

Other data illustrating this phenomenon is the number of certificates withdrawn. Notified Bodies withdrew 1.881 CE marks in 2016 – which is all-time highest result. The amount of CE certificates withdrawn has increased over 7 times since 2010 (when 244 certificates were taken away). There are plenty of reasons for withdrawal, on both Manufacturer’s and Notified Bodies’ side, such as:

  • OBL (Own Brand Labelers) reduction,
  • transferred Notified Body,
  • closure of location,
  • company reorganization or bankruptcy,
  • Notified Body being too expensive,
  • non-conformities not closed or requirements not met,
  • lack of payment

 

2016: a year of ISO 13485

In 2016 Notified Bodies were more focused on granting ISO certificates. There were 23.484 valid ISO 13485 certificates issued – 19% more than CE. It is a record high result since 2010. The number of ISO 13485 certificates awarded keeps steadily increasing since 2013.

Professional EU Consultant

As the findings of the TEAM NB survey show, choosing a right Notified Body becomes nowadays a challenge. The Manufacturers have to make sure that Notified Body they are considering to work with is accredited and even more importantly, that it is available and able to carry out certification on time.

Should you have difficulties choosing a Notified Body, you are advised to hire a professional EU Consultant. Obelis, being one of the largest consultancy centers in Europe and having 30 years of regulatory experience, will gladly support manufacturers in the process of choosing a suitable Notified Body for the CE certification. If you wish to know more about this service, please feel free to visit our Notified Body Selection page or contact us.

Katarzyna Piekarska

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