October 3, 2019 EU MDR

RAPS – 2019 Regulatory Convergence Round-up by MakroCare

Recently concluded RAPS- 2019 regulatory convergence at Philadelphia, PA was attended by a good number of representatives from pharma, biotech and device industries, from vendors offering services in various regulatory areas and also by notified bodies. One of the themes of this conference was related to device regulations –MDR and IVDR. As EU Medical Device Regulations (MDR) and In-Vitro Device Regulations (IVDR) will be applicable by May 2020 and May 2022 respectively, the device industry is keen to get update on these regulations, to understand the implementation strategies better, learn from other companies to get better clarity on the new requirements to make their devices MDR or IVDR compliant.

The various sessions were planned to address some of the questions from these representatives and provide better transparency about MDR and IVDR applications. The speakers were experts from big, small device companies, from the vendor side and also from Notified Body (NB). The key sessions included like QMS implementation of MDR & IVDR, managing requirements of EU MDR GSPR, IVDR 2022, European IVDR state of implementation, Review and Compilation of clinical data in a CER, develop strategies to obtain clinical data for legacy device for CE marking etc.

As new regulations provide more emphasis on the clinical data requirements of the individual device, those relevant sessions were highly attended by the representatives. Everybody is trying to get an understanding of clinical data requirements to support the safety and performance of the devices and the industry is trying to find an answer to one nagging question about the clinical data is how much enough is enough. These sessions covered topics like the use of databases, inclusion/exclusion of criteria for clinical data and SOTA searches, documenting SOTA in CER, establishing SOTA relationship with conformity assessment and overall strategies for coming up with a quality CER. The speakers also covered clinical evidence and demonstration of compliance of the devices and requirements of PMCF wherever needed. The sessions also highlighted various sources to collect the data to build clinical evidence related to performance and safety for all devices including legacy devices as grandfathering is not allowed under new regulations. There were case studies and lessons learned presented to show how companies faced challenges and paved the way while transitioning from MDD to MDR.

Similar session related to IVDR 2022, covered IVDR implementation activities such as gap analysis related to technical files, clinical data, and QMS activities. It emphasized training, effective internal coordination/communication, monitoring and aligning implementation activities as per the new requirements. The session also covered legacy devices and performance evaluation plan to support intended use and claims.

There were also sessions on other changes related to MDR and IVDR such as UDI (Unique Device Identification), new requirements for drug-device combinations products, regulatory strategies and change management, medical device harmonization across regions and Impact of MDR etc.

There were many exhibitors comprises of big device companies like Medtronic, Stryker, different vendors offering various services and technology in regulatory areas and also few notified bodies and some of them have already designed for EU MDR.