he final texts of the new European Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) have been published in the Official Journal of the European Union today. The Regulations will enter into force on May 26th, marking the start of the transition period for manufacturers selling medical devices into Europe.
Read the full EU Commission press release here
Medical Device Regulation
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.
The MDR, replaces the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC), and has a transition period of three years, after which the Regulation will apply, and no new applications against the Directives will be accepted. Manufacturers have the duration of the transition period to update their technical documentation and processes to meet the new requirements. Manufacturers can apply for certificates to the new Regulation once their notified body is designated.
This long awaited text brings with it more scrutiny of technical documentation; it addresses concerns over the assessment of product safety and performance by placing stricter requirements on clinical evaluation and post-market clinical follow-up, and requiring better traceability of devices through the supply chain.
In Vitro Diagnostic Regulation
REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU.
The IVDR, which replaces IVD Directive (98/79/EC), has a transition period of five years, after which the Regulation will apply, and no new applications against the Directives will be accepted. Manufacturers have the duration of the transition period to update their technical documentation and processes to meet the new, more stringent requirements. Manufacturers can apply for certificates to the new Regulation once their notified body is designated.
The new IVD Regulation marks a significant shift in the regulatory environment for IVDs. It introduces a number of substantial changes to the requirements, including a new rule-based classification system for products, superseding the current list-based approach. The shift to a rule-based approach will considerably increase the number of IVD manufacturers who require a notified body to certify their products as classification rules are applied to all IVDs, rather than using an exclusive list of specific products to determine which require a notified body. The IVDR also introduces new concepts within the area of performance evaluation and clinical evidence.
The nature of these changes is reflected in the length of the transition period for manufacturers; the five year transition period was agreed to provide time for manufacturers to make the necessary changes to their technical documentation and processes.
Gary Slack, Senior VP, Global Medical Devices at BSI said, “The regulatory landscape for medical devices is a rapidly changing one, and with that comes the transformation of Medical Device and IVD Regulation. We welcome the increased requirements under the two Regulations, facilitating a good balance that allows medical device manufacturers to further prioritize patient safety whilst continuing to provide timely access to innovative medical device technology.”
Organizations need to familiarize themselves with the new regulatory requirements now and evaluate the impact this will have on their entire product range sold in the EU. To assist organizations, BSI has produced a suite of materials to support this regulatory change: