Dr. Max D. Singh, Global Director – Orthopedic Focus Team, TÜV SÜD Product Service GmbH
Immense attention must be paid as currently the regulatory clearance system for medical devices in the EU is facing dramatic changes in this sector with regards to the Medical Device Regulation (EU MDR 2017/745).
Since the MDR will become fully applicable in May 2020, there is not much time left for all stakeholders to fully comply with all requirements. Even the legislators at the European level still work on adaptions (e.g., latest published corrigendum of the MDR) and expert panels mandatory for reviewing technical documentation are not formed, yet.
There are some concerns related to orthopedic devices; three of them will be highlighted in this article. Addressing them is of ample importance for the whole medical device industry since the orthopedic sector is one of the largest and fastest-growing disciplines due to, amongst others, demographic needs.
Regulatory consequences at a glance
Affected by one fraud-situation regarding breast implants plus another design-related issue concerning a hip joint prosthesis leading to severe damages to patients in both cases, legislators re-visited the planned regulation to include more scrutiny and set up a more stringent vigilance system. Manufacturers are required to demonstrate compliance with the General Safety and Performance Requirements (GSPR) set in the MDRin Annex I. For implantable and class III devices a pre-market clinical investigation is required, and the equivalence demonstration will become more limited for those devices. Additionally, it is necessary to collect post-market data (PMS) systematically and actively to obtain more real-world data from the use of the devices. This is relevant for orthopedic and spinal devices, as some of them will be up-classified and most of them fall under the highest risk classification for medical devices in the EU. The EU MDR also puts the Notified Bodies (NB) under more stringent scrutiny to ensure better oversight and higher consistency in the assessment of the different NBs.
Essential changes in the new EU MDR include:
1. Stricter pre-market control of certain class IIb and class III implantable devices with the involvement of at the Expert Panel EU level.
2. More stringent criteria and qualification requirements for the designation processes of NBs.
3. Inclusion of certain aesthetic products, the so-called devices without medical purpose (devices falling under Annex 16) which represent the same characteristics and risk profile as “he same medical devices. Some orthopedic medical devices are used not only for a reconstructive indication but also for solely aesthetic signs, e.g., craniomaxillofacial plates for the transgender population.
4. EU-wide database (EUDAMED) for medical devices´EUDAMED) for medical device, and post-market surveillance.
5. EU-wide requirement for an 'implant card' to be provided to patients as part of higher traceability of medical devices.
6. Changing rules on clinical data requirements for the various device classifications.
7. Reinforced need for manufacturers to collect data about the real-life use of their devices after placing them on the market.
Some specific properties of orthopedic devices will set an additional burden and are presented in the following.
Specific questions of orthopedic devices under the scope of the MDR
The already existing up-classification of joint replacement devices for hip, knee and shoulder prostheses as Class III devices has been extended per Annex VIII 5.4. Rule 8 of the MDR to all total and partial joint replacement devices. Additionally, certain spinal disc replacement devices and implantable devices that come into contact with the spinal column will be up-classified to Class III with some exceptions. A position paper from Team NB and NB MED was presented to the EU Commission in early 2019 with the goal to enable a risk-based and pragmatic approach to classification of spinal devices according to the EU MDR.
Due to short or long-time complications of orthopedic devices, revision procedures are common. For those revision cases, primary implants or specialized revision implants could be used. Since there are a lower number of revision cases compared to primary implantations, the collection of clinical data could be more cumbersome. This is also relevant for post-market data which needs to be presented in the PMCF-Report.
Another aspect to consider is the huge number of legacy devices. They need to fully comply with the requirements of the MDR, as every first application under the EU MDR will be considered as an initial application. There will be no grandfathering for legacy devices. This could have an impact on the number of available orthopedic and spinal devices on the EU market. Manufacturers should have a plan in place by now addressing these aspects and enabling them to collect the relevant data before applying for the new legislation.
This article only highlights some of the aspects relevant for orthopedic and spinal devices under the EU MDR.
In the end, the main goal for all stakeholders should be to ensure that only medical devices which are safe, performing as intended and with a benefit-risk profile which is positive when compared to the current state of the art will have access to the EU market under the new framework.