Communicate with Your Notified Body
As the legal manufacturer of a medical device, the failure to communicate effectively and within the correct timescale may risk your regulatory approval and ability to sell in a specific market. As a result, the processes and interfaces that contribute to effective communication are more important than ever.
The changing relationships between the stakeholders in the medical device market are directly impacting the nature and type of communications needed for manufacturers to operate successfully. There are relationships and therefore communications between a medical device’s legal manufacturer and, the European Competent Authorities, other regulatory authorities, notified bodies, distributors or importers, clinical users, component suppliers, critical sub contractors and OEMs. As some of these relationships move from being a commercial relationship to more of a commercial marriage or partnership, so the communication channels need to change. For example, if manufacturers are to avoid regulatory issues, and in extreme cases loss of certification and inability to trade in the EC or elsewhere, intermittent updates may need to be upgraded to an ongoing dialogue.
Relationship with your Notified Body
The publication of the EU Commission Recommendation on audits and assessments, with the introduction of regular unannounced audits has emphasised the importance of better communications. This article gives advice on the importance of communicating, in particular with your notified body.
Prior to April 2014, the date when most notified bodies started to undertake unannounced audits, many manufacturers relied on being contacted once a year by their notified body to consider what they should have previously communicated to them. For example, this could have been re allocation of activities between sites, change of contact name, changes in important suppliers, changes in critical sub contractors or the commencement of a clinical trial. The notice of a future audit prompted this information to be sent to the notified body, and in some cases this was only explained at the audit’s opening meeting. With an unannounced audit it will be too late. It is not acceptable for a notified body to arrive at a site only to discover it no longer manufactures product, or visit an OEM supplier whose contract expired six months ago. This would be an expensive lack of communication because all notified bodies will charge the cost of unannounced audits, even if they are subsequently rearranged at a different location.
The lines of communication which must work effectively are those between the legal manufacturer and their notified body, as well as between the legal manufacturer, their critical suppliers and subcontractors. In very rare cases, when it is anticipated that a notified body may have to take samples from the distribution chain, communications with distributors could also be important, but this is unlikely to be a common scenario.
Many notified bodies, including SGS, have realised that the new obligations imposed by the September 2013 EU Commission documents required changes to client contracts and more detailed obligations on both sides. This presented an opportunity for notified bodies to formalise the notification of information and changes from the manufacturer to the notified body, to cover all the new requirements including unannounced audits. The new process covers the provision of more detailed information and updates on activities and product ranges at each certified site, plus regulatory actions and clinical trials, critical suppliers and sub contractors, times of factory closure and sometimes production schedules. SGS asks its clients to always use a standard electronic form, to clarify the process.
To initiate the unannounced audit process, SGS, sent a simple questionnaire to all clients requesting confirmation of their activities site by site, the names and address of critical suppliers and sub contractors as well as the dates of any factory closures. Even after reminders, the return rate was only about 25%. This raised the prospect that some manufacturers hoped to avoid or delay unannounced audits. Such evasive action was a short sighted hope, since the audits are a requirement from the Competent Authorities and SGS will schedule them whether this information is confirmed or not. However, in the interests of good client relationships, most notified bodies do not want to arrive at a location only to find that a successful unannounced audit cannot take place. Hence, they are actively trying to confirm the relevant information, either during a scheduled audit or by other means, and it is in the interests of manufacturers to comply.
Having received this initial information, it is then vital that manufacturers update their notified bodies in real time, with changes in their critical suppliers and sub contractors, movement of product related activities and shutdown periods.
The intention has been to ensure that communications between critical sub contractors and the legal manufacturer of devices being own brand labelled, in particular OEM manufacturers, is a dialogue between partners. This would ensure that both sides had all the information required to carry out their respective legal obligations. Much of this communication must now be specified in the contract between the two parties. It must cover aspects such as the provision of technical documentation, the notification of design changes, the feedback of complaints and adverse events from the market.
Having agreed with their notified bodies which suppliers are considered critical, manufacturers must communicate this information to them and ensure that the contract allows the notified body to undertake unannounced audits at their supplier and sub contractor sites. In the same way that the legal manufacturers must keep the notified body informed of changes that could affect the unannounced audit, so these critical suppliers and sub contractors must update their customer, the legal manufacturer, of changes in location, production schedules and so on.
Many manufacturers have yet to appreciate the impact the increased responsibilities of their notified body will have on their internal communication and change systems. The major focus of unannounced audits is to check whether the device being manufactured and tested is exactly as described in the technical file, and that manufacturing processes are exactly as described in procedures and work instructions. If internal change control and communication has not ensured that process improvements, changes in critical component suppliers and new production methods have been promptly and correctly translated into changes in the technical file, manufacturers should expect major non conformities to be raised. These internal lines of communication must work better than many did previously.
Best Practice for Manufacturers
It is obvious that change control and the communication of agreed changes to the interested parties (internal and external) is more important than ever. There are two important actions for manufacturers to consider and document. Firstly, to define who in the organisation has the responsibility to inform the appropriate parties and how this should be achieved. For example, a defined person should have the responsibility to inform the notified body of all the relevant changes and they should understand how this is achieved. In the case of SGS, this would be by the mandatory SGS Notification of Changes form.
Secondly, the processes must be operated and documented so that all those with responsibilities to inform other parties, for example, the notified body, the purchasing department and the critical supplier, should be either involved with the change process, or at least be informed immediately the decision is made. This will ensure that vital communications are not forgotten and that regulatory compliance is maintained.
There is very little that is genuinely new with respect to communications, but as with other aspects of manufacturer control unannounced audits focus attention on the negative consequences and costs of poor communication, especially with your notified body.
For further information, please contact:
SGS Global Manager- Medical Devices
Global Medical Device Office
202B Worle Parkway, Weston-super-Mare, BS22 6WA,