Notified Bodies have a crucial role in the CE Marking process. Below you will find an overview of the role of Notified Bodies and what is important when selecting and changing the provider.
What is a Notified Body (NB)?
A NB is a third-party organization that has been designated by a EU member state’s competent authority to carry out tasks related to conformity assessment procedures for the applicable legislation. In our case, the applicable legislation refers to Regulation (EU) 2017/745 on medical devices (MDR), Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) and to the Medical Devices Directive 93/42/EEC (MDD), the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) and the In Vitro Diagnostic Medical Devices Directive 98/79/EC (IVDD).
The involvement is not necessary for medical devices of class I unless they have a measuring function or are sold in sterile condition or (only applicable for the MDR) are reusable surgical instruments. For IVD products, a NB is only required when the product is listed under annex II of the IVDD. Under the IVDR all products need an NB unless the device falls into class A.
Selection of a NB
It is vital to choose the right NB for your organization – changing the NB may be challenging and expensive in many ways. In addition, the number of NBs has decreased over the past years. With the MDR and IVDR becoming fully applicable in May 2020 or May 2022 respectively, this bottle-neck is expected to increase. To date, only four NBs have been designated for the MDR and none for the IVDR. It is important to select an NB who will continue to be designated under the MDR and IVDR.
Independent from the low availability of MDR and IVDR NBs at present, we outlined some important preparatory steps to consider when selecting an NB below:
- Set up a team
- Determine individuals responsible for the selection process
- Team should include representatives at least from regulatory and quality department
- Prepare a company and product summary, including details like
- a company description
- the number of employees and relevant manufacturing processes
- suppliers and subcontractors used
- device descriptions of products that are to be sold under the EU legislation
- chosen conformity assessment procedure
- desired schedule
- Based on the summary, you may develop a preference list to pre-select 3-5 potential NBs, e.g. based on
- legislation and product types they are currently designated for
- regulations and assessment methods they are seeking re-designation for
- office locations
- language skills
- required specific areas of expertise
Once you have pre-selected potential organizations, you may request additional information as listed below to finalize your decision. Please be aware that not all of these items might be available upon request:
- detailed quotation with services and fees
- audit checklists
- information package
- application package
Change of the NB
The reasons for changing a NB can be manifold: For example, a manufacturer may acquire certain products that have been CE marked under a different NB. Sometimes, poor customer service and low availability in times of timely pressure is an issue. Currently, it certainly is the unsafety regarding the MDR/ IVDR and Brexit that play a central role.
Notwithstanding the reasons, changing the NB is a highly formal process. Several aspects should be considered and followed:
- The Notified Body Operations Group (NBOG) issued a guidance document that provides important insights about the change process (VERLINKEN).
- It is prohibited to have two outstanding applications with two separate NBs.
- It is highly recommendable to set up an agreement and plan between you, the outgoing NB and the incoming NB that details all aspects affected by the change, e.g.:
- invalidity of certificates of outgoing NB
- dates of new certificates
- obligations regarding labeling
- responsibilities and timelines
- Against the points above and in coordination with the outgoing and incoming NB, you should make sure that old labels are not used longer than six months after the new certificate is available – unless duly justified. The point in time when the switch to the new labels will take place, should be clearly defined.
Do you want to know more or require assistance in finding or changing your NB? Please get in touch with us and find out how we can help you!
Sources: MDR, IVDR, MDD, AIMDD, IVDD, NBOG guidance