Regulatory strategy

 We help medical device companies meet regulatory requirements and ensure safety and performance during the entire product lifecycle in Europe, the US and other markets.

Our regulatory strategy services cover: 

• Outlining regulatory pathways
• Documenting target market requirements
• Suggesting qualification and classification for each target market
• Quality and regulatory knowledge in design and development processes
• Preparation and update of technical documentation
• Establishing a Clinical/Performance Development plan

Regulatory lifecycle for medical devices

Medical device definitions vary in different parts of the world, as well as classifications and requirements. Therefore, it is critical to consider your target markets in your regulatory plans to ensure efficient product development, a smooth market registration process, and reduce time to market.

Regulatory plan

When you plan to bring a medical device to the market, applicable regulatory requirements need to be identified. A regulatory plan is established to address applicable regulatory requirements, based on qualification and classification of the product, as well as the product characteristics. Suitable standards and applicable guidances are identified to support compliance. This includes the applicable regulatory path, called the conformity assessment procedure for the device, which differs per market. In the EU, conformity assessment procedures are set out in Article 52 and Annexes IX to XI of MDR (2017/745), and in Article 48 and Annexes IX to XI of IVDR (2017/746). For other markets, conformity assessment is defined in the applicable regulation.

After gaining market access, the manufacturer must monitor their devices, maintain technical documentation and inform the authorities of changes and incidents when mandatory. Also, changes in the regulatory landscape for the device must be monitored and considered. We have experts that monitor changes in the regulatory landscape and perform the activities needed to maintain medical devices on the desired markets, including post-market surveillance. Most markets require active post-market surveillance and reporting of incidents and safety updates to authorities.