Transferring, or changing, a notified body is no small decision for a medical device manufacturer. The notified body can be seen as a partner in the manufacturer’s certification for their medical devices, so there is a lot riding on the relationship. Regardless of the reasons for transferring, however, manufacturers can freely transfer between notified bodies.
Reasons Why Manufacturers Transfer Notified Bodies
The Notified Body Operations Group, NBOG, outlines some reasons for switching notified bodies, drawing a line between situations where the change is voluntary or involuntary for the manufacturer.1 A voluntary change is when a manufacturer switches notified bodies, whereas an involuntary change is due to the stopping of a certification body in this area when the notified body can no longer provide its services. Because notified bodies, and the certification they offer, are key to a manufacturer’s success, a manufacturer may be fearful of changing their notified body. Switching notified bodies does not, in fact, change anything with regard to the previously-certified product, provided the notified body issued valid certificates.
According to NBOG, the notified bodies must agree to the extent the old notified body’s labeling can be used. There is no need to re-label any existing product, as the NBOG also states that the CE marking done by one body is exclusive to those products. This means that product batches already certified by the old notified body retain their CE marking, even though the manufacturer or distributor no longer uses the notified body. New or newly manufactured device batches must display the new notified body’s CE mark, but there is no reason to re-label duly CE-marked devices.
Voluntary changes are those where the manufacturer itself changes from one NB to another. Essentially, it is in the best interest of all parties involved to work together to figure out and compromise on the various aspects to cover in switching NBs. NBOG outlines some points in particular that should be discussed between the two NBs and the manufacturer:
• When the existing certificates’ become void;
• The duties of the manufacturer to inform each NB of any notifications, when the transfer starts and when it is complete;
• The manufacturer’s duty to work with each NB to determine when and how the manufacturer will re-label any devices that need it;
• Which party has the responsibilities regarding conformity assessment tasks and a quality system survey;
• Which notified body owns which documents generated for the conformity assessment procedure;
• How much transferring will cost for the manufacturer.
Enforced or Involuntary Changes
Involuntary changes are those where the NB itself either loses its accreditation or the NB withdraws its accreditation from a type of certification. In these cases, the previous NB has the duty to inform the manufacturer at the earliest possible moment of their actions and until when the manufacturer’s certificates are valid. This includes cases in which a certificate may be invalid immediately as a result of the previous NB’s inadequate assessments. Regardless, the outgoing NB must immediately inform the manufacturer of any issues with the certificates and work with the manufacturer to provide any relevant information to ease the transfer process.
Important Documents Governing Transferring Notified Bodies
There are two international documents that provide rules and guidelines for both NBs and manufacturers when switching NBs. The International Accreditation Forum (IAF)2 created the IAF Mandatory Document for the Transfer of Accreditation Certification of Management Systems, which went into effect in 2008. According to the Document, it provides “…normative criteria…[and] minimum criteria for the transfer of certification.”3 Even though the Document was created for management systems, which is a voluntary certification, it can be used for NBs. The Document lays out the minimum requirements for transferring NBs, including the accreditation of the certification body, the extent of the pre-transfer review, and requirements for the transfer process.
More specifically for CE-marking procedures, the Notified Body Operations Group (NBOG)4 created a set of guidelines that provide manufacturers a background and outline of when to change NBs and the process of changing.5 The NBOG document focuses on the reasons why a manufacturer would change NBs and some important things for all parties to consider. LNE/G-MED follows these two documents closely in helping clients switch NBs in order to be better serve its clients.
Upcoming Important Documents – Medical Device Regulations
In 2012, the EU Commission proposed sweeping changes to the current medical device regulatory scheme that includes changing to how notified bodies would operate. Included in the proposals are procedures and criteria to re-notify the notified bodies to the future regulations, when they come into effect. In addition, the EU Commission issued Regulation 920/2013 on the designation and supervision of notified bodies, which included criteria for notified bodies to retain their notifications before the new regulations come into effect. As a result of these changes, some notified bodies have already lost their notifications. It is expected that more notified bodies that can’t support the requirements would lose their notifications. This would result in more involuntary transfers with which manufacturers would need to contend.
When a Manufacturer Transfers, What Do They Do?
For the notified body, a transfer means that the new notified body will take over the old notified body’s certification. Naturally, in order to do this, the new notified body would do its own due diligence on the certification before taking it over. This means that the certification must meet specific prerequisites and the manufacturer needs to supply the new notified body with some documentation.
Prerequisites for Transferring Notified Bodies
To transfer notified bodies, a manufacturer should have some documents and certificates at the ready for the new notified body to validate. Additionally, there are a few more prerequisites for a manufacturer or distributor to transfer notified bodies. To transfer notified bodies, the manufacturer or distributor must have:
• Valid certificates for the products;
• The address for the manufacturing sites, which must be the same as those on the valid certificates
• The devices must be within the same scope of the previous certificates;
• There must be no threat to the certificates, meaning the certificates must not be predicated on fixing non-conformities; and
• Enough time to transfer the certificates.6
It is reasonable to assume, however, that some manufacturers may not have all these necessary documents. [Contact us] to talk to one of our expert technical staff for more information on how to transfer notified bodies.
Important Documents to Include
When transferring notified bodies, the manufacturer should include in their file:
• All current cycle audit reports from the previous notified body;
• All certificates for the product that will be transferred;
• A letter from the manufacturer authorizing the transfer;
• A report of any non-conformities and the action plan to fix any non-conformities; and
• A report of any adverse events, like customer complaints and recalls, since the last audit.
These documents will give the new notified body a full view of the product and the previous assessments in order to best provide manufacturers and authorized representatives a full view of the services that the new notified body can offer. Even though this may raise the price of transferring for the manufacturer, further proof of a conforming product is never a bad thing for the manufacturer’s bottom line.
Each notified body’s transferring process is a bit different. LNE/G-MED’s process eases the burden on medical device manufacturers and helps to smooth out what could otherwise be a rocky path to a new relationship with LNE/G-MED. For more information on transferring to LNE/G-MED, contact us.
1 NBOG Best Practice Guide, 2006-1.
2 According to the Document, “The International Accreditation Forum, Inc. (IAF) operates programs for the accreditation of bodies that provide conformity assessment services. Such accreditation facilitates trade and reduces demand for multiple certification.”
3 IAF MD2:2007 0.1, 0.3.
4 The NBOG’s objective is, “To improve the overall performance of Notified Bodies in the medical devices sector by primarily identifying and promulgating examples of best practice to be adopted by both Notified Bodies and those organisations responsible for their designation and control.”
5 NBOG Best Practice Guide, 2006-1.
6 IAF MD2:2007 2.2.1.