Significant changes ahead for medical device manufacturers
Medical device manufacturers will soon be confronted with major changes in the EU’s decades-old regulatory framework which governs market access to the European Union (EU). The MDR will replace the EU’s current Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC).
The Medical Device Regulation was officially published on May 5th 2017 and came into force on May 25th 2017. Manufacturers of currently approved medical devices will have a transition time of three years until May 26th 2020 to meet the requirements of the regulation. For some manufacturers the new regulation provides an additional time after the date of application allowing them to place new products for max. 4 more years on the market. Additional requirements will apply for this extended transition period.
How can TÜV SÜD help you?
The new MDR imposes strict demands on medical device manufacturers and the Notified Bodies whom they must involve in the approval process of medical devices other than self-declaration class I devices.
For over 30 years, TÜV SÜD has provided market access solutions and expert partnership for manufacturers and suppliers of medical devices and in vitro diagnostics. Our services put your product through its paces and ensure medical device market approval and acceptance.
We have in-depth knowledge of the medical devices and IVD market and our dedicated team of over 700 experts, engineers, and medical doctors provide assessments that cover the full life cycle of your products. We are global, multilingual and have experts in all major markets who provide tailored advice for ensuring your medical devices are approved and accepted.
The MDR differs in several important ways from the EU’s current directives for medical devices and active implantable medical devices. The most significant changes in the regulation include:
Product scope expansion - The definition of medical devices and active implantable medical devices covered under the MDR will be significantly expanded to include devices that have not a medical intended purpose, such as coloured contact lenses and cosmetic implant devices and materials. Also included in the scope of the regulation are devices designed for the purpose of “prediction and prognosis” of a disease or other health condition.
Identification of “qualified person” - Device manufacturers will be required to identify at least one person within their organisation who is ultimately responsible for all aspects of compliance with the requirements of the new regulation. The organisation must document the specific qualifications of this individual relative to the required tasks. Special relief may apply to so-called micro and small enterprises.
Implementation of unique device identification - The MDR mandates the use of unique device identification (UDI) mechanisms. This requirement is expected to increase the ability of manufacturers and Authorities to trace specific devices through the supply chain, and to facilitate the prompt and efficient recall of medical devices that have been found to present a safety risk. In addition, the European Databank on Medical Devices (Eudamed) is expected to be expanded to provide more efficient access to information on approved medical devices.
Rigorous post-market oversight - The MDR request increased post-market surveillance authority by the Notified Body. Unannounced audits, along with product sample checks and product testing will strengthen the EU’s enforcement regime and help to reduce risks from unsafe devices. Annual safety and performance reporting by device manufacturers will also be required in many cases.
Specifications - The MDR plans to allow the EU Commission or expert panels to be defined to publish Common Specifications which shall then be taken into account by manufacturers as well as Notified Bodies. These Common Specifications shall exist in parallel to the Harmonized Standards and the State of the Art.
Reclassification of devices according to risk, contact duration and invasiveness - The MDR will require device manufacturers to review the updated classification rules and update their technical documentation accordingly by considering the fact that class III and implantable devices will have higher clinical requirements and a regular scrutiny process.
More rigorous clinical evidence for class III and implantable medical devices - Manufacturers will need to conduct clinical investigations in case they do not have sufficient clinical evidence to support the claims done on both safety and performance of a dedicated device. Device manufacturers will also be required to collect and retain post-market clinical data as part of the ongoing assessment of potential safety risks.
Systematic clinical evaluation of Class IIa and Class IIb medical devices - Manufacturer will need to re-prepare their clinical evaluation by considering the new wording of the regulation on when an equivalence approach and under which circumstances it is possible to justify not conducting a clinical investigation.
No "grandfathering" provisions - Under the MDR, all currently approved devices must be recertified in accordance with the new requirements. Exemptions are under negotiation right now.
Conformity assessment procedures
The complex development process for most types of medical devices, combined with the need to address new regulatory requirements and obtain Notified Body approval, is likely to make the transition a complicated and time consuming process for most device manufacturers. Further, currently approved devices are not exempt from the requirements of the new regulation and will need to be re-evaluated and re-approved.
Since a large number of medical devices will now require Notified Body review and approval, delays in the review and approval process by Notified Body should be expected. Therefore, it is recommended that manufacturers of currently approved devices consult with their respective Notified Body to evaluate potential compliance issues and to develop a plan to address them promptly. Advanced preparation and early action will be key to ensuring a smooth transition to the new requirements.