In May 2017, the new European Union Medical Device Regulation (MDR) was approved by the European Parliament and was published in the Journal of the European Union.
The new MDR represents a very-significant change in the regulatory environment and it is important that all manufacturers prepare and build a comprehensive strategy to guarantee compliance.
The new MDR represents a very-significant change in the regulatory environment and it is important that all manufacturers prepare and build a comprehensive strategy to guarantee compliance
According to consulting firm, Emergo, the majority of industry professionals cite the changing regulatory environment as their biggest challenge.
In order to overcome this, and not be overwhelmed when it comes to implementing the new MDR; it is imperative for manufacturers to take a pro-active and pragmatic approach to reviewing their existing processes and to ensuring a comprehensive plan is in place.
The aim of the MDR is to bring about a robust, transparent, predictable and sustainable regulatory framework for medical devices, which will maintain a very-high level of safety within the healthcare industry, but will also help push companies to drive innovation.
Conforming with the new requirements of the MDR may be a long and tricky process as all existing and new products on the market need to be phased into the new system.
It is imperative for manufacturers to take a pro-active and pragmatic approach to reviewing their existing processes and to ensuring a comprehensive plan is in place
There will also be an added administrative burden which will be placed on manufacturers, with staffing and external cost budgets needing to be monitored properly.
Here are 10 pragmatic tips which manufacturers can follow en route to MDR compliance.
1. Know the risks of non-compliance: Ensure management understand the importance of the new MDR and the possible consequences that could occur. This means that a cross-functional team is built to take overall responsibility for MDR implementation and can be positioned to take over some, or all, aspects of it.
2. Senior management need to take control: Manufacturers should be assessing the situation and performing detailed gap analysis for products and the whole organisation against the new MDR. This means the detailed requirements need to be studied and special consideration needs to be given to certification expiry dates versus transition periods and enforcement dates.
3. Ensure product liability insurance is in order: Manufacturers need to be able to provide sufficient financial coverage for their potential liability. It is suggested that they review their product liability provisions and seek legal counsel to do so.
4. Stay organised and anticipate administration challenges: Try and foresee any organisational and administration challenges which might unexpectedly arise, for example staffing availability and capability as well as budget restrictions.
5. Keep monitoring: Continue to monitor and keep a look out on the actively-changing regulatory environment.
6. Check and check again: It is important to check the classification rules and confirm conformity assessment routes for any existing and future products in order to be able to act on any necessary changes.
7. Engage with Notified Bodies as early as possible: With a new amount of pressure building on Notified Bodies and their capacity; it is important that they are contacted in a timely fashion in order to ensure that they have availability to service the implementation plan. As well it is important to prepare for any unannounced inspections from Notified Bodies.
8. Assess the gaps: It is important to address any apparent gaps in Clinical Evaluation Reports as well as ensure that PMS provisions are adequate.
9. Check the QMS: Review the adequacy of Quality Management System (QMS) processes and plans to transition to ISO 13485:2016 and build in the new regulatory requirements into the QMS.
10. Nominate the PRRC: The Person Responsible for Regulatory Compliance needs to be adequately trained and suitably qualified for the role. Overall, it is important that manufacturers do not underestimate the time and effort that will be required to ensure all parts of the business meet conformance requirements. A detailed roadmap and competent project managers are needed to drive the new regulations through in order to ensure the EU medical device market houses the safest and top-performing devices.