Advice and best practices for writing SOPs, training for product launch, outsourcing technical documentation, and more.

5 New EU Medical Device Regulations That Will Make You Rethink Your Documentation Plan

medical_technical_writer-resized-600The European Commission is expected to finalize new proposed directives for medical device compliance this year, with implementation from 2015 to 2018. For medical device manufacturers that sell in Europe, these new regulations could mean longer product launch timelines and changes to documentation practices. Here are a few likely changes to be aware of, and tips for how your team can manage them…  

5 EU Regulations That Will Affect Documentation

1. Review by Notified Bodies 

It is expected that 80% of in-vitro diagnostic (IVD) devices will require approval from a Notified Body, up from 20% currently. In addition, some medical devices will be reclassified and require new design certification.

“Until 2011, more than 30% of Class III and 40% of Class IIb medical devices in Europe were marketed without clinical studies of any sort. Now Notified Bodies are challenging clinical evidence not only for new higher risk class III and IIa devices but also existing devices…even those that are lower risk class IIa and I sterile/measuring devices.”  –NAMSA

What you can do:

  • Choose the right Notified Body to review your documentation.
  • Determine whether any classification changes will affect your products and current certifications.

2. Unexpected Audits

Notified Bodies are now authorized to make unannounced Quality Management System audits of medical device manufacturers and their suppliers. In compliance with these audits, manufacturers are required to provide all technical documentation related to quality systems, including access to suppliers’ documentation.

What you can do:

  • Make sure your quality management system and documentation are up-to-date and accessible.
  • Ensure that your supplier agreements address access to technical documentation.
  • Assign roles and responsibilities to team members, and make sure they know what to expect from the audit. On-demand training may be helpful.
  • Establish a standard operating procedure (SOP) for handling unannounced audits. (Here are 5 SOP Best Practices).

3. A Second Opinion

According to the new directives, before a Notified Body awards CE certification, authorities may take a closer look at the Notified Body’s review of the technical documentation. This can mean longer wait time for approval.

What you can do:

  • Identify what technical documentation is required, and make sure it is up-to-date.
  • Follow the SOP for handling unannounced audits mentioned above.

4. UDI Labeling

The new EU regulations (as well as new FDA regulations in the United States) will require all devices to be labeled with unique device identifiers (UDIs). These codes allow individual parts to be tracked through the supply chain and in their end use, and manufacturers will need to include them in product documentation.  Some formatting changes to documentation are also expected, as well as greater disclosure of the risks associated with each product.

What you can do:

  • Ensure that medical devices are properly labeled.
  • Review technical documentation regularly and update as needed.

5. Nanomaterial Guidelines

The European Commission has also published new safety guidelines on the use of nanomaterials in medical devices. Any device that allows the release of nanoparticles into the body is considered class III, or high risk.

What you can do:

  • If your medical device includes nanomaterial, update your technical documentation accordingly.
  • Make sure that biocompatibility standards are met and that documentation is up-to-date (e.g. ISO 10993).

Download our Tip Sheet: 6 Strategies for Managing Risk & Budget in Product Launch

Get Tip Sheet

Topics: Quality System documentation, Process documentation, product launch, regulated industries, medical device launch