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Impact of the European Union's New Regulations on the Medtech Industry

Medtech companies marketing their products in the EU will have to seriously consider the impact of regulatory changes on their current and future products and operations.

The life sciences sector is going through a period of unprecedented regulatory changes affecting the pharmaceuticals, medical devices and in-vitro diagnostics industries. In 2017, the European Union released new regulations to ensure patient safety that will go into effect in 2020 and 2022. The intent of these new regulations is to:

  • Strengthen the regulatory platform across the EU
  • Promote a shift from the pre-approval stage to a lifecycle approach for regulating medical devices
  • Seek to harmonize and simplify the rules
  • Provide transparency and product traceability

The new regulations replace the predecessors MDD 93/42/EEC (Medical Device Directive) and AIMDD 90/385/EEC (Active Implantable Medical Device Directive) with the MDR 2017/745 (Medical Device Regulation) and IVDR 2017/ 46 (In-vitro Diagnostic Medical Devices Regulation) These new regulations have been guided by the Global Harmonization Task Force (GHTF) and the International Medical Device Regulators Forum (IMDRF), emphasizing the importance of a global convergence of regulations. Major changes include the following and many more:


  • Reclassification of products will decide change of current method of conformance
  • Notified bodies who can grant product certifications will undergo recertification and will have to conduct increased audits and review extensive technical/clinical data, which will cause longer lead times for certification.
  • Responsibilities of authorized representative (AR) and other economic operators (EO) like distributors or importers will increase and also share the burden of product liability
  • Greater emphasis on clinical data
  • Mandatory inputs into EUDAMED (European Database for Medical Devices) and other databases, leading to increased work and modifications to quality management systems(QMS) and clinical reports
  • Introduction of unique device identifiers
  • Greater burden on post market surveillance (PMS) and clinical follow-up will call for PMS planning and implementation. Periodic safety update reports (PSURs) and field safety corrective actions will have to be updated in the EUDAMED database
  • Adverse event reporting time will be reduced to 15 days from 30 days of date of event.
  • Implementation of a risk management plan across product lifecycle and a risk/benefit analysis
  • QMS and PMS audits will occur at least yearly, unannounced inspections once every five years

Medtech companies marketing their products in the EU will have to seriously consider the impact of these changes on their current and future products/operations. Compliance with the new regulations will be mandatory in order to retain or obtain the CE mark, which is a must for any product being sold in the EU market. As the changes are so extensive, med device companies will have to take a structured and well managed approach over the next three years to implement a compliance plan. This will require a multi-disciplinary and cross-functional program and governance team lead by regulatory experts.

Companies will need to conduct a gap assessment to determine the remediation steps required for a given product and establish a cost of compliance. Depending on the remediation effort required and the resulting cost of compliance, companies may decide to remediate or retire a product, based on the product revenue at risk. A typical implementation framework could be as shown in the flow chart below.

  1. High Level Impact Assessment
    • Find the right partner to assess the changed environment
    • Engage key internal stakeholders
    • Understand product families and classification
    • Determine product specific compliance requirements

  2. Gap Analysis
  3. Determine gaps in:

    • Technical documentation
    • Clinical evaluation data
    • Quality management system
    • PMS and complaints handling
    • Commercial side – AR and other economic operators
    • IT Technology for handling operational aspects

  4. Planning
  5. Based on impact assessment and gap analysis:
    • Conduct portfolio assessment
    • Establish financial implications – revenue risk and cost of compliance
    • Get leadership commitment
    • Determine best solution to tackle change – resources (internal or outsourced)

  6. Communicate and Audit
    • Effectively communicate impact of MDR across the organization
    • Handle change management to ensure that implementation is successful
    • Mock audits for quality system and documentation
    • Ensure stakeholder alignment

  7. Implementation
    • Establish a cross-functional governance and program management team
    • Conduct training of all stakeholders on MDR requirements
    • Implement required changes in QMS, PMS, design processes, technical documentation, IT infrastructure and organization structure

Regulatory executives and the business unit leaders will have to carefully sequence these activities in order to be compliant with the MDR timelines. Effective tracking and communications across stakeholders should be a part of the governance process and the process should be standardized across all product lines. As expenses associated with MDR compliance could run into high dollar amounts, earmarking financial resources for this task is a must. The implementation plan must have the blessings of senior leadership.

MDR compliance will neither be cheap nor easy, but companies that proactively implement the plan will stand to gain in the longer term. Organizations that use this opportunity to drive positive internal change are more likely to be successful in the future of a changing regulatory landscape. The new regulations and monitoring systems will make it easier to identify issues with products in the field. Such data will help med device companies build trust with patients, physicians and regulatory bodies and also strengthen the perception of the CE mark.