Dec 22, 2020

UDEM Adriatic d.o.o., based in Zagreb, Croatia, is a new name in the EU Notified Body community. They have been officially listed in the European database for Notified Bodies, NANDO, designated for the upcoming Medical Devices Regulation (EU) 2017/745 (MDR). Their Notified Body number is 2696. UDEM is not listed there as Notified Body for the Medical Devices Directive 93/42/EEC (MDD), and therefore it appears there is a new Notified Body available.

Limited scope

The scope of UDEM is limited. For example, the firm cannot certify active implantable devices (MDA 0101-0104). Other examples of exclusions are: active non-implantable devices using ionizing or non-ionizing radiation (MDA 0301-0302) and active and non-active devices for processing and preservation of human cells, tissues or organs (MDA 0314 and MDN 1212). There are also limitations to the horizontal scope codes. For example, codes MDS 1002 and 1003, regarding devices manufactured utilizing tissues or cells of human or animal origin, or their derivatives, are not covered. This means that it is very important to carefully investigate the available expertise before reaching out to UDEM as well as other Notified Bodies for certification.

UDEM presents an interesting option

The requirements for designation of Notified Bodies to MDR is covered by strict rules and procedures. These will have been applied to UDEM, just as they have been applied to organizations that have already been designated. That means that certificates issued by UDEM will have exactly the same value as certificates issued by much larger and better known Notified Bodies: They will allow manufacturers of devices covered by those certificates to apply the CE marking to their products, and place them on the EU market.

The fact that UDEM does not cover all scope codes could be used as a strength. The so called “narrow scope” Notified Bodies are typically interesting for smaller organizations with a limited product portfolio. Where “broad scope” Notified Bodies might be very busy with large corporations, a narrow scope Notified Body may be able to pay more attention to smaller clients. Of course this requires careful consideration. UDEM may not have offices all over the world, which will make on-site audits more expensive, and if your portfolio grows, you may outgrow their scope.

Following UDEM’s designation, there are now 18 Notified Bodies able to certify medical devices under the MDR:

  • UDEM Adriatic (Croatia)
  • GMED (France)
  • DEKRA Certification (Germany)
  • DOS Medizinprodukte (Germany)
  • MDC Medical Device Certification (Germany)
  • Medcert Zertifizierungs- und Prüfungsgesellschaft für die Medizin (Germany)
  • TÜV Rheinland LGA Products (Germany)
  • TÜV SÜD Product Service (Germany)
  • CE Certiso Orvos (Hungary)
  • National Standards Authority of Ireland (NSAI) (Ireland)
  • IMQ (Instituto Italiano del Marchio di Qualita) (Italy)
  • BSI Group The Netherlands (The Netherlands)
  • DARE!! Services (The Netherlands)
  • DEKRA Certification (The Netherlands)
  • DNV GL Presafe (Norway)
  • 3EC International (Slovakia)
  • Intertek Medical Notified Body (Sweden)
  • BSI Assurance UK (UK)

Ronald Boumans is Senior Consultant, Regulatory Affairs at Emergo by UL.

Related European MDR and Notified Body resources from Emergo by UL:

 

 

Author

  • Ronald Boumans

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