As manufacturers across the sector continue to progress through their Stage 1 and Stage 2 audits toward EU MDR and IVDR compliance, many are encountering common challenges along the way.
At Advena, we’ve supported numerous clients in successfully navigating this complex transition — and along the journey, we’ve gathered valuable insights.
Here are key lessons we believe every manufacturer should know to help avoid the pitfalls of non-compliance:
- Ensure the obligations under article 10a around continuation of supply is enshrined somewhere in the quality system.
- Provisions for record retention in the event of bankruptcy must be clearly stated in the quality system. Your Quality Manual may be a good place to record this.
- Risk assessments and obligations under ISO14971: 2019 will be an area of focus. This is not new under the MDR but it is definitely a recent area of focus in audits. The auditor will often take a specific high risk and follow it through to the product release or process controls. Your risk assessments should relate to the measures you have actually put in place to mitigate risks.
- CAPAs that relate to product or process should have a link to the risk management procedures. You can either enshrine this in the forms for CAPAs the process or both. You need to be able to present evidence that your risk documents are living documents that are revisited when new information is received. New identified risks or changes to probability of existing risks should both be considered as a result of this.
- Make sure your Management Review is robust, if you state you consider training/new regulations ensure that there is a specific section covering this. If there are no changes state that this has been considered.
- Make sure your methodology for controlling external documents is robust and up to date. They will likely review your access to standards that you reference, and they will expect you to understand the ramifications of the latest version.
- Supplier control should be risk based, and critical suppliers/sub-contractors should have controls proportionate to the products/services supplied. Ensure your contracts with suppliers contain provisions that allow you to meet the regulatory requirements under the EU MDR.
- Is design control in scope? If you have design as part of the scope of your certification, make sure that the process is robust and links to the information required for your technical file. If you have claimed a specific output for the finished product/processes required ensure there is evidence that this has been verified or validated.
Contact Us
For further information and personalised guidance, please feel free to reach out to Advena via either our website contact page, www.advenamedical.com, email (info@advena.com) or phone (01926 800153) to start a conversation today.
