OBL Guidance to Clients
This article is now obsolete and has been replaced by our article on Virtual Manufacturing, which has replaced OBL. Press here to be redirected.
As you are probably aware there have been significant changes to the requirements of Own Brand Labelling [OBL] in relation to the MDD 93/42/EEC and IVDD 98/79/EC contained in the Commission Recommendation 2013/473/EU, which was released in September 2013.
This document made clear the Commission view that OBL manufacturers should be viewed in the same way as all other legal manufacturers of medical devices and should not be subject to a lighter conformity assessment process
The following email is therefore being sent to explain these expectations and the requirements that you as the legal manufacturer will be required to carry out.
One area which has already been completed is the process of ensuring that annual on-site audits are conducted, no longer can the complete CE certification process be completed off-site. SGS have already informed those affected clients of this change and from the end of June 2014 we will not be conducting any more of these purely off-site audits.
The main point to state is that the previous concept of OBL being able to pass responsibilities to their OEM is no longer acceptable; the concept is now that you will be considered to be “virtual” manufacturers. Other important changes are as follows.
You will still require to have a formal agreement with the Original Equipment Manufacturer [OEM] as presently which will define the responsibilities of each party but no longer can an OBL delegate any regulatory function to the OEM, these must now be fully under the control of the OBL.
The formal agreement as a minimum must include the following:
- A direct link between the OEM and OBL products
- Provision of technical documentation by the OEM to be held by the OBL
- Notification of design changes by the OEM to the OBL prior to implementation and updating of the technical documentation held by the OBL
- A clause allowing access to the OEM’s full technical documentation by regulatory bodies and your Notified Body.
- A clause allowing your Notified body to undertake unannounced audits at the OEM
- Responsibility for design, translation and affixing of labelling and IFUs
- Arrangements for Customer Complaints ,Vigilance, FSN, Post Market Surveillance and Post Market Clinical Follow Up activities and the communication of any issues between the two parties.
- Document Retention Times
- Traceability requirements.
Access to OEM technical documentation
The OBL as a minimum must have a copy of the STED [Summary Technical Documentation as defined in the GHTF document SG1/N011R20 for medical devices or GHTF/SG1/N063 for IVD devices], this is sometimes known as Part A of the technical file.
This STED document will be reviewed as part of the yearly on-site assessment audit or if as an OBL you have a large number of STED’s a sample will be checked. We will not be conducting a full in-depth technical review of the STED as the full technical file should have been reviewed by the OEM’s Notified Body but if we do find significant omissions from the STED then we will raised Major Non-conformities on the OBL.
If there is any specific propriety information of a confidential nature in the full technical file it is accepted that this information may not be passed to the OBL. This policy has been confirmed as acceptable by the regulatory authorities but the rationale for this omission will be reviewed during the audit and it is expected that the OBL will be aware of the omission of this data.
Discover more about Advena’s Medical Device Regulatory Consulting and Quality Management Services, or contact us on +44 (0) 1926 800 153 or via email to firstname.lastname@example.org