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:
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:
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.
Determine gaps in:
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.