The optimum frequency for an unannounced inspection should be once in three years and more regularly for Class III products. If the organization or the supplier has initiated a “cause for concern” with your notified body or a European competent authority, then you will receive a surprise inspection despite the recommended frequencies. Here are the six Steps to ensure that you are prepared for EU notified body unannounced inspections.
1. Be ready
Set up and examine the sources of information for sudden and unannounced inspections. Ensure you generate links with other businesses in the area with the same notified body and products. Assess your contract with your notified body and make sure you identify when you are developing a product. Communicate this to your notified body.
2. Prepare for unannounced audits
Carry out formal business continuity planning actions to make sure you take into consideration worst-case scenarios and extend measures that could be used later for drills and simulations. These dealings could then serve as the basis for your business continuity strategy.
3. Initiate mock audits on your own
The best method to be prepared for audits is by undertaking mock audits. This method would help you in self assessment and you can learn lessons in the business and refine your emergency procedures.
4. Execute steps for unexpected inspections
It is vital to have procedures to inform and train everyone involved in unannounced inspections so that they can apply them the moment an unannounced inspection occurs. This must also be extended to your supply chain.
5. Beef-up awareness and train suppliers
The best method to prepare for EU audits is to train your people and suppliers so that you can use evaluation techniques to understand whether they are able to emergency plan, apply unannounced audit procedures and effectively respond to notified body requests during the audit. Do not underestimate the significance of having skilled and confident people on hand whenever an audit takes place.
6. Maintain compliance to the EU directives
Are you sure all your medical devices are correctly classified? Is your technical file updated with the right information? If not, please ensure that you get a technical file review, a hazard management review and post-market inspection summaries corresponding to your data is done. Maintain documents and evidence to prove that your device is in accordance with medical device directive’s essential requirements.