Global Compliance

Strategic Planning for Compliance With the EU Medical Device Regulation

Compliance with the EU Medical Devices Regulation (MDR) is a significant undertaking that requires cross-functional collaboration. In this post, we explore key activities involved in strategic planning for compliance.

Establishing a leadership team

Good leadership is essential for managing the transition to EU MDR compliance and creating an execution strategy which includes timelines and mechanisms for tracking progress on compliance activities. At a minimum, this leadership team should include representatives from Regulatory Affairs, Quality Assurance, Medical and/or Clinical Affairs, Marketing, Manufacturing, Biocompatibility, Sterilization, R&D, and Labeling. This leadership team must be actively engaged in communicating with the Notified Body, as well as establishing project harmonization amongst business units and product portfolios.

Identifying a person responsible for regulatory compliance

Under the EU MDR, manufacturers are required to identify a person responsible for regulatory compliance. This person should be a subject matter expert on the product portfolio and its safety and efficacy, and they should have the credibility to speak to those matters should questions be posed by regulatory authorities or the general public.

Conducting a gap analysis

One of the first questions for manufacturers to ask when conducting a gap analysis is whether their existing products are compliant with the current EU Medical Device Directive (MDD). If not, they will need to find a way to be compliant with the EU MDD as soon as possible in order to apply for re-certification. Or, in some cases, manufacturers may opt to remediate their files for existing products to be compliant with the new MDR rather than re-certifying.

A gap assessment can help manufacturers determine which compliance strategy is most appropriate for them. At a minimum, manufacturers should perform:

  • Technical gap analysis
  • Regulatory gap analysis
  • Clinical gap analysis

As a gap analysis is specific to the manufacturer, the therapeutic area, and the product or family of products, each gap analysis is unique. However, the objective of every gap analysis is the same: to identify areas of non-compliance and then remediate them to not only bring the product to compliance but also sustain that compliance.

Allocating resources to support compliance activity

The effort involved in compliance with the EU MDR is substantial, and it is critical to invest both budgetary and human resources in this activity. Work related to compliance with the new regulation is an added responsibility, likely one with which a manufacturer’s current employees have little to no experience. For manufacturers who lack the necessary expertise, it is in their best interests to budget for and hire the right subject matter experts who can bring the company into MDR compliance and train employees to maintain compliance.

Completing key compliance Activities

Strategic planning for MDR compliance will need to include:

  • Development of an MDR project plan, which encompasses remediation/compliance activities, manufacturing and supply chain considerations, and labeling
  • Creation of a comprehensive list of products in the product portfolio, including their classifications and the cadence required for MDR compliance
  • Establishment of resource planning
  • Assessment of the rest of world (ROW) impact that may be a ripple effect of MDR compliance, including review and possible revision of global registrations outside of the EU

Minimum technical documentation requirements for compliance with the EU MDR include:

  • Manufacturing Information
  • Design Information
  • Design Risk/Benefit Analysis
  • Production Risk/Benefit Analysis
  • Clinical Evaluation Report
  • Sterilization
  • Biocompatibility
  • Device Lifetime
  • Risk Management Report
  • Post-Marketing Surveillance Follow-Up (PMSF) Plan and Report
  • Summary of Safety and Clinical Performance (SSCP)
  • Periodic Safety Update Report (PSUR)
  • General Safety and Performance (GSPR) Checklist
  • List of Applied Standards
  • Transport and Packaging
  • Restricted Substance Justification
  • Declaration of Conformity

Seeking outside assistance

For assistance with strategic regulatory planning, manufacturers can hire consultants who have experience with EU MDR compliance activities. These consultants can assist with developing a robust strategy, conducting a gap assessment, communicating with the Notified Body on the manufacturer’s behalf, and even creating pilot files. Pilot files are worst-case technical documents for a particular product or family of products. These files are submitted to the Notified Body for review and comments, and this feedback is then used to enhance and broaden compliance activities for the remainder of the product portfolio.

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