European Medical Device Regulations: A Challenge for Notified Bodies and Manufacturers

The European Union (EU) published its new European medical devices regulation and in vitro medical devices regulations – MDR (EU) 2017/745 and IVDR (EU) 2017/746 – in May 2017. In the intervening months, it has become clear the adoption of these new regulations presents a considerable challenge to both manufacturers and Notified Bodies (NB).

The new regulations replace the current EU Medical Devices Directive – MDD 93/42/EEC. The challenge for stakeholders is encapsulated by the fact the new regulation has nearly quadrupled in length and now uses the word ‘safety’ 290 times, up from 40 in the MDD.

The key driver behind this dramatic increase in length is the need for enforcing higher levels of public health and patient welfare. It is clear, however, the European Commission (EC) also has other objectives for these regulations. Firstly, the EC wants to see harmonization in the comprehension and interpretation of medical devices (MD) and in vitro diagnostic devices (IVD) regulations, creating greater transparency and a more unified approach across Europe. Secondly, the EC wants to encourage new operators who are open to innovation but defined within the legal framework.

This increase in scale is applicable to both MD and IVD, with stakeholders finding their relevant regulations now cover roughly three-times the number of pages, with a resulting increase in complexity. For MD, for example, the number of articles has risen from 23 in the MDD to 123 in the MDR, and the number of annexes has also risen from 12 to 17. Similar increases are also seen in the regulations for IVD.

IMPROVED SAFETY REMAINS THE KEY DRIVER FOR THE NEW LEGISLATION.

THE REQUIREMENTS INCLUDE:

• Stricter control for high-risk devices via a new pre-market scrutiny mechanism with the involvement of a pool of experts at EU level
• Reinforcement of the criteria for designation and processes for oversight of Notified Bodies

New roles are created:

• Responsible person in each manufacturer ensuring regulatory compliance
• Project leader by NB

Extended certification scope, such as:

• Devices without medical purpose (annex XVI of MDR) but presenting the same characteristics and risk profile as analogous medical devices under the scope of these regulations
• Broader IVD range of products
• Reusable products, etc.
• New risk classification system for in vitro diagnostic medical devices in line with international guidance
• Implementation of a European database (EUDAMED) and an improved tracking system with UDI (Unique Device Identifier) that will improve transparency and give access to MD data to competent authorities, users and patients
• Introduction of an “implant card” containing information about implanted medical devices for a patient
• Introduction of a coordinated EU-wide procedure for authorization of multi-center clinical investigations, with reinforced clinical evidence requirements
• Strengthening of post-market surveillance requirements for manufacturers
• New vigilance rules and market surveillance for manufacturers and Notified Bodies

It is clear the implementation and maintenance of these new requirements, for both manufacturers and NB, will induce significant cost increases, both in terms of finances and resources. SGS specialists have estimated the expanded requirements for IVD, the more time-consuming of the two, may generate a 70% increase in time taken. This stems from the greater number of tasks undertaken to achieve certification. It can be surmised that, since a dearth of resources for providing certification already exists, a bottleneck might be created as manufacturers try to achieve certification with already stretched NB resources.

Stakeholders should already be aware that MDR will become mandatory on May 26, 2020, and IVDR becomes mandatory on May 26, 2022. In theory, there has been a transition period of three years for manufacturers and NB but the first Notified Body has been designated in February 2019 and still the only one as off today. The next one should not be designated before Summer 2019, this means there will only be a nine-month period between NB designation and the mandatory requirements for MDR coming into force.

Stakeholders should remain cognizant of the potential for bottlenecking in the certification process and consider their position to ensure continued regulatory compliance during the transition. The problem may be amplified by the increased demands being placed on NB, which may also mean some NB’s leave the marketplace.

SGS’s three Notified Bodies’ organization in Belgium, Finland and the UK are already engaged in the process to become designated NB to the new regulations. The investment in time and resources is significant but SGS is committed to providing fast and efficient compliance services for manufacturers of medical and in vitro diagnostic devices.The European Union (EU) published its new European medical devices regulation and in vitro medical devices regulations – MDR (EU) 2017/745 and IVDR (EU) 2017/746 – in May 2017. In the intervening months, it has become clear the adoption of these new regulations presents a considerable challenge to both manufacturers and Notified Bodies (NB).