How will Emergo and UL support the MedTech Industry?
The MedTech industry has entered a period of rapid change with the publication of the MDR and IVDR on May 5th, 2017. Industry will be looking to both its Notified Bodies and consultants to help them on the journey ahead and in market access, whether they want to work with us as either their certification body or their consultant. UL is committed to helping its customers and the addition of Emergo to its global capabilities gives customers a choice of how to get the most value out of the UL relationship.
How can UL provide consultancy to its medical device and IVD customers when it is also a Notified Body?
In order to best serve our customers, we have put a lot of effort into making sure the controls are in place to avoid the concern of conflict of interest. Typically conflict of interest occurs when a person (or entity) is engaged in activities of determining conformity as an independent 3rd party. This outline serves to provide clarity and direction under abundance of caution because we recognize that having both entities in the same company may cause the perception of conflict of interest. UL will continue to stay away from commercializing a product, branding/marketing a product as the manufacturer, or taking on design ownership of products. This notice is not intended to be all inclusive, and changes/edits/updates may occur as needed.
UL takes impartiality very seriously, it is the cornerstone of our Mission and business ethics and we recognize that it is essential to support both our brand and in turn our customers’ brands. In order to continue to comply with the regulations and serve our customers, the following have been considered, and are being implemented:
1. Separation of legal entities
To mitigate perception and risk, UL has taken care to ensure that there is clear separation between both legal entities. This applies to its organizational and management structure. The medical device Notified Body is not co-located within the same legal entity as any UL company operating consultancy activities
2. Separate processes, operational activities, and customers
UL and Emergo do not share any operational processes and do not have access to each other’s client records. The UL medical device Notified Body and Emergo will not share the same customers. The Notified Body has processes in place to ensure its independence and impartiality is maintained. Processes are being put in place to ensure that any potential conflict of interest is addressed. Until determined otherwise, UL will not be able to provide both Notified Body services to an Emergo client, and Emergo cannot act as the Authorised Representative or consultant to a UL Notified Body customer. Over the next few months, during the transition, we will work closely with existing shared clients to make sure their needs are met. UL conformity assessment certification activities related to the CE-marking under the EC Medical Device and IVD Directives and Regulations will remain separate from any Emergo activity.
3. Separate branding
Emergo has a strong brand and identity within the industry and it will continue to operate under this brand, whilst Emergo has joined the UL family its activities remain separate from all certification activities and maintaining the brand helps clarify this in the market place.
4. Separation of sales activities
We will work with customers and determine their needs across UL’s broad service offerings. Our sales force will keep the consultancy quotations, contracts, pricing and sales processes separate from any certification services.
5. Separation of marketing and website
We will avoid confusion in marketing and web based literature about the relationship between UL and Emergo by maintaining separate branded assets. This will help make it clear that the consulting services are separate from certification services. We are maintaining separate web properties and adding statements to both websites to clarify the separation between the organizations.
6. Separation of staff
The Notified Body senior management, operations and delivery staff are all separate from the Emergo staff and there is no regular interaction between the groups. As the integration continues, Emergo will share corporate functions such as Finance and Human Resources.
The UL family of companies provides services across a wide array of industries from commercial and industrial to ensuring that consumer products like fridges and toasters are safe. The UL mark has been a mark of safety and quality for over 120 years. In order to deliver services across all these industries including the MedTech sector we rely on having appropriate accreditations and designations, whether it be ISO 17021, ISO 17025, ISO 17065 or the requirements of the Medical Device and IVD regulations, all these have specific requirements to maintain independence and impartiality, the following diagram out lines which services can be provided to the same customer and which must be separated to ensure we maintain appropriate separation and maintain independence and impartiality. UL has for a +120 years and will continue to provide science based, testing services as it relates to technologies and scientific principles. These reports may be used by our clients for a wide variety, with authorization from UL.
As we enter a new regulatory era in the MedTech space UL looks forwards to working with all its customers to meet the challenges ahead.