MDR impact on QMS

The new MDR goes into effect — the European Parliament voted on the 17th of April to postpone implementation of its new Medical Device Regulation (MDR) by one year. The previous directive will no longer exist or be applicable to quality systems.

MedDevs should follow what is now known as “General Obligations” to ensure compliance for their QMS. It can be found in the new MDR.

What it entails

As stated in the MDR, medical device companies shall establish, document and implement a quality system, and maintain its effectiveness throughout the entire medical device lifecycle. In the MDR, every stage of the life cycle has taken into account more effectively. As the requirements for, e.g., vigilance and post-market surveillance procedures are now tightened up: medical device companies will be obliged to collect data about their performance.

So, it’s recommendable to pay more attention to the post-market surveillance system. It should be planned, established, documented, implemented and maintained.

An updated systematic procedure to review experience gained from devices in the post-production phase should be established. This must be done for the purpose of identifying any need to immediately apply any necessary CAPA.

Incidents and field safety corrective actions are addressed in Articles 87–89. The MedDev companies should make sure the new regulations are met and to ensure that SOP outlines new requirements for reporting incidents and FSCAs.

MedDev companies should have the system for technical documentation as a process in their QMS. The technical documentation should be created mainly during the design and development process of a device and the design team should have a template and procedures for it.

Expanding the SOP

Supply management is affected as well. So, it would be preferred if SOP would outline the process of medical device identification and traceability throughout the supply chain.

A new requirement under MDR addressed in Article 27 is UDI. So, the SOP for UDI and labeling should be identified including storage of the UDI at each level and the process for importing UDI information into EUDAMED.

All medical device companies should have within their quality system a defined strategy for regulatory compliance. It might result in defining a new SOP. Also, companies should have a designated person responsible for regulatory compliance. It should be documented who this is and what their roles are.

Updates

The policy for document and storage retention isn’t new, but it has been updated. The documentation for medical devices must be retained for 10–15 years (depending on the type of device) after the last medical device was placed on the market. It should be confirmed that QMS is effective throughout the extended storage period.

With MDR, there is more emphasis placed on clinical evidence for demonstrating continued device safety and intended clinical benefits and positive effects on patient health. MedDev companies will have to ensure they have processes in place to ensure that there is sufficient quality data to conduct a qualified assessment regarding product safety and intended clinical benefits.

Complying with MDR requirements will be highly complex because changes touch elements of the companies QMS a lot. Documenting the QMS is necessary to have a robust system, preferable electronic, allowing you to easily keep it updated and transparent.