Cynthia Lambert, Regulatory and Industry Specialist, Pilgrim Quality Solutions
There are significant changes on the regulatory horizon in Europe due to the publication of the new European Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR), which were approved by the European Parliament on April 5, 2017. The industry is now subject to a three-year transition period for compliance among medical devices, and a five-year period for compliance among in vitro diagnostic (IVD) products.
The new regulations provide for:
- a consistently high level of health and safety protection for EU citizens using these products;
- the free and fair trade of the products throughout the EU; and,
- EU legislation that is adapted to the significant technological and scientific progress occurring in this sector over the last 20 years.
Key Focus Areas within the New EU Medical Device Regulations
Numerous quality, compliance, and risk-related processes will be affected by the new regulations. At a high level, the new regulations require:
- stricter preliminary control for high-risk devices via a new pre-market scrutiny mechanism, with the involvement of a pool of experts at EU level;
- the reinforcement of the criteria for designation and processes for oversight of Notified Bodies;
- the inclusion of specific aesthetic devices which present the same characteristics and risk profile as equivalent medical devices under the scope of these Regulations;
- the introduction of a new risk classification system for in vitro diagnostic medical devices in line with international guidance;
- improved transparency through the establishment of a comprehensive EU database on medical devices, and of a device traceability system based on Unique Device Identification;
- the introduction of an “implant card” containing information about implanted medical devices for a patient;
- the reinforcement of the rules on clinical evidence, including an EU-wide coordinated procedure for authorization of multi-center clinical investigations;
- the strengthening of post-market surveillance requirements for manufacturers; and
- improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance.
Preparing for the Changes
Formal implementation of the new regulations is required by 2020 for Medical Device manufacturers and 2022 for IVD manufacturers. Even though that may sound like sufficient time to adopt new changes, resources should be allocated to adapt to these stricter, more complex requirements well in advance.
Additionally, these changes will require attention to the quality management system per ISO 13485:2016. Medical Device manufacturers must ensure that the policies and procedures around the implementation of their Technical Files address nonconforming products, corrective and preventive actions (CAPA), complaints, internal auditing, training records, and change control as Notifying Body assessments will be conducted in a strict and structured manner.
Choosing the Right QMS for ISO 13485:2016 Compliance
Increasing Liability for Authorized Representatives
Per the European Commission, Authorized Representatives play a major role in dealing with both pre-market and post-market compliance and regulatory issues, on behalf of manufacturing clients. That role will continue under the new MDR and IVDR. However, one change under the new regulations may have significant ramifications for how quickly or easily foreign manufacturers may find and establish partnerships with Authorized Representatives. Namely, the MDR will hold Authorized Representatives jointly liable, along with manufacturers, in cases where devices sold on the European market are found to be defective.
This change has major implications for foreign manufacturers, as firms offering Authorized Representative services will now share increased liability for their products. Foreign manufacturers should expect more thorough due diligence and scrutiny from potential Authorized Representative partners who now will incur liability they did not have before. Foreign manufacturers also may undergo additional monitoring by their Authorized Representatives for post market compliance.
Considerations for CE Mark Certification
For foreign manufacturers that have no physical presence in Europe, establishing a partnership with a European Authorized Representative is crucial (and required) for CE Mark certification and successful commercialization. Under Europe’s current medical device and IVD Directives, Authorized Representatives act as liaisons between foreign manufacturers and national Competent Authorities.
Despite the official timeframes, changes already have begun to affect Europe’s Notified Body sector. Manufacturers are likely to have fewer Notified Bodies to choose from and to partner with for CE Mark certification, quality system inspections, and related functions going forward. Therefore, it is imperative that medical device companies ensure that their Notified Body is still going to be valid, and a thorough review of the CE Marking status of their products should be conducted.
Strengthening Compliance with an Automated Quality Management System
The onset of these new regulations means that your quality and compliance management systems must be more comprehensive than ever before. An automated quality management solution such as Pilgrim SmartSolve® supports your compliance efforts with consistent, risk-based workflows to manage nonconformances, CAPAs, customer complaints, and other quality processes.
How is your organization preparing for these new regulations? Let us know in the comments below.