The New EU Medical Devices Regulation (MDR) and In vitro Diagnostics Regulation (IVDR) were approved by the EU Parliament on April 5, 2017. The final regulations, expected to be published in May 2017, would trigger a transition starting date of – or around – June 1, 2017. More specifically, the transition periods for the MDR and IVDR are three (3) and five (5) years, respectively.
Increased Regulatory Oversight
The new regulations dramatically increase the regulatory rigor to obtain and maintain Conformité Européene (CE) Marking, especially in regards to pre- and post-market clinical data and evidence. Class III and implantable device manufacturers will be required to conduct clinical trials for all devices. However, in lieu of clinical trial data, Class III and implantable device manufacturers may claim equivalence to devices owned by another company if they have a contract with that company granting full access to their proprietary technical documentation.
Although manufacturers of lower class devices will not be not required to have a contract in place, they will still need to demonstrate that they have sufficient access to related data pertaining to the equivalent device. It is important to note that even if a manufacturer is able to utilize published data from the equivalent competitive device organization, the requirements for extraction, analysis and presentation of the data are expected to become more onerous.
Increased Use of Clinical Evaluations Reports
Existing IVD and medical device organizations may be tasked by a manufacturer to conduct the clinical evaluation and prepare a Clinical Evaluation Report (CER), and meet specific education and experience requirements. With the increased importance of the CER in the CE Mark assessment process, it behooves manufacturers to have a gap assessment performed comparing their CERs against the MDR and MEDEV 2.7.1 requirements and prepare a mitigation plan as soon as possible.
Aside from the increased clinical evidence requirements, the revised MDR results in ‘up-classification’ of multiple devices. These include surgical meshes, spinal disc replacements, and implants that contact the spinal column, which will now be considered Class III devices. Reusable Class I instruments must now be reviewed by the Notified Body (NB), similar to Class I sterile devices.
Greater Impact to IVD Manufacturers
Although the MDR changes will significantly impact the medical device industry, this pales in comparison to the IVD marketplace. Under the current system, only 10-20 percent of IVDs require NB certification. This rate is expected to increase to 80-90 percent under the new IVDR. Additionally, the new regulation requires preparation of Clinical Evidence Reports, a new concept for IVD manufacturers.
Technical Files for devices and IVDs will need to be overhauled to meet the new requirements and NB expectations. This process should include a gap assessment between the current MDD/IVDD Essential Requirements and the new General Safety & Performance Requirements to identify whether additional data must be generated to demonstrate compliance to new or revised requirements. Bringing Technical Files up to the new standards will be especially painful for manufacturers that have products that were previously self-certified, as historically they have been minimally compliant.
Increased Oversight of Notified Bodies
Manufacturers won’t be the only entities impacted by the new regulations, but Notified Bodies will experience a significant impact given greater oversight by the Member States and EU regulatory bodies. Existing NBs must reapply for NB designation under the new regulations. It is expected that approximately 50 percent of NBs may not be re-notified, or may have their scope reduced.
Successful IVD and Medical Device Manufacturers Will Start Planning Now
Although three and five year transition periods seem rather long, given the many implementation changes that will be required, the expiration dates will come before manufacturers realize it. The time to start discussing a strategy and detailed road map is now if IVD and medical device firms wish to not only be adequately prepared, but also successful under the new regulations.
Identifying the Right Regulatory Strategy
The new EU regulations will significantly impact already resource-constrained device manufacturers, making it potentially even more difficult to navigate this unique regulatory landscape. That’s why having the right partner from the start can be invaluable in achieving successful implementation and market success.
NAMSA’s global regulatory experts welcome the opportunity to discuss the new IVDR and MDR regulations with you, including potential business impacts – and more importantly – how to plan for success.