EU Medical Device Regulations: Are You Prepared for the Impact?

Manufacturers, importers and distributors of medical devices in the EU must comply with all the applicable new requirements by May 26, 2021.

To help you understand and prepare for this impact, our NSF team has created five steps to comprehend the business impact to products already on the market and new product introductions in Europe:

• Read or take educational courses to understand the background of the changes and the product safety and regulatory influences that are shaping the structure of medical device regulation in Europe, including the European regulatory framework.
• Prepare a plan identifying your product groups likely to face the most significant impact and establish a team capable of undertaking a business impact analysis.

• Conduct a gap assessment to understand how the regulations will affect your current product portfolio by assessing how the changes may impact notified body involvement, postmarket reporting or the suitability of technical documentation to demonstrate product safety and performance.
• Prepare a plan identifying the products most affected by the change and identify the necessary additional actions and costs to address these impacts.

• Understand your new product introductions to determine if the changes may immediately impact your net present value and return on investment calculations based on a tougher regulatory system.
• Prepare a plan for your commercialization portfolio that challenges the product-to-market assumptions and organize your product-to-market projects by risk impact.

• Understand your current organizational structure and determine if you have the necessary legal coverage, IT infrastructure, people and processes necessary to work within the boundaries of the new regulations.
• Prepare a plan detailing your internal and external commercial entities prioritized by risk and an operational plan of action.

• Understand that these plans will need a robust impact analysis appropriately timed to manage immediate, short-term and long-term regulatory compliance.
• Prepare a business impact assessment covering your whole business, clearly consolidating the overall resource impacts of the changes on current and future product portfolios.