Europe Dumps Its Regulatory System. Confusion Reigns

The narrative had become quite comfortable.

It is easier to get your new medical device through the European Union (EU) regulators than the U.S.’s FDA regulators.

The rules were clear. You knew what to do. Hire the right consultants, get your ISO 13485 certification, pay the price for clinical studies and jump over the regulatory hurdles that gave you access to hundreds of millions of potential customers. The hurdles served as a barrier of entry to your competitors.

A Fundamental Change for Device Suppliers

Then, in April of 2017, the Europeans blew up the narrative by repealing its existing “directives” on medical devices. The new Regulation would go into effect in May 2020. Device companies gulped, consultants cheered and our lines at OTW lit up. Device makers wanted to know what to do.

Device makers will be facing a new set of rules which will fundamentally change medical device commercialization in the EU.

The European Commission is calling this a “soft transition” in the sense that it is supposed to allow companies to keep certain aspects of the current CE Mark applications while following new registration requirements, if their Notified Bodies (NBs) approve.

Sounds good. Except…there are no guidance documents to explain the complicated, interlocking requirements.

What are the Europeans doing and what will it mean for device makers? We dug in.

What Happened?

On April 5, 2017, the Europeans passed the European Union Medical Device Regulation [MDR], (Council Regulation 2017/745 of 5 April 2017 concerning medical devices, OJ No L 117/1 of 2017-05-05). The Regulation repeals the existing directives on medical devices: Medical Devices Directive [93/42/EEC] and Active Implantable Medical Device Directive [90/385/EEC].

Currently approved medical devices will have a transition time of three years [with a staggered transition period until May 26, 2020] to meet the new MDR requirements.

The new regulation introduces new responsibilities for national Competent Authorities (CA) and for EU Notified Bodies.

During the transition period, manufacturers can place devices on the market under the currently applicable EU Directives but must comply with certain aspects of the EU MDR when it goes into effect in May 2020 such as post-market surveillance and vigilance requirements. Manufacturers may also submit their applications to be certified fully under the MDR during the transition period if their NBs are certified to accept EU MDR applications.

New scientific opinions will be required for a host of devices, such as bone cement containing an antibiotic. Any existing product must be recertified to abide by the new regulation.

Most companies, according to published reports, will be required to collect clinical data, and update technical documentation and labelling.

Unique Device Identification (UDI) will be enforced to help track devices throughout the economic operator supply chain and will be added to all labels.

Under the new regulation, medical devices will continue to have to undergo a conformity assessment to demonstrate that they meet legal requirements to ensure they are safe and perform as intended as under the current MDD. However, the conformity assessment under the MDR is expected to be tougher with increased scrutiny on the manufacturer’s supporting data. EU Member States can designate accredited notified bodies (NBs) to conduct the conformity assessments.

The conformity assessment usually involves an audit of the manufacturer’s quality system and, depending on the type of device, a review of technical documentation from the manufacturer on the safety and performance of the device.

Once the conformity assessment has been passed, manufacturers can place a CE (Conformité Européenne) mark on its devices.

“Important Improvements”

According to the European Commission, the new Regulation contains a series of extremely important improvements to modernize the current system. Among them are:

• impose stricter ex-ante (based on forecasts, not actual results) control for high-risk devices via a new pre-market scrutiny mechanism which would also involve a pool of experts at EU level
• reinforce Notified Body oversight designation and process criteria
• add certain aesthetic devices under the scope of device Regulations which, the commission’s view, have characteristics and risk profiles which are analogous to medical devices
• improve transparency by establishing an EU medical device database and method for tracking devices using Unique Device Identification markers.
• introduce for patients an “implant card” which has information about any implanted medical device
• reinforce clinical evidence rules via an EU-wide coordinated procedure for authorization of multi-centre clinical investigations
• strengthen post-market surveillance requirements for manufacturers
• improve EU country medical device vigilance and market surveillance coordination mechanisms

Yeah, But…

The biggest concern reported by regulatory consultants is that Notified Bodies will not be designated in time or have the capacity to deal with newly up-classified devices in addition to their existing portfolios. And fewer Notified Bodies are expected to be available because some have already said they will not stick around under the new regulation.

In fact, on July 24, the U.S. urged the EU to delay implementation of the new regulation by three years to allow for U.S. exporters to adapt to the new requirements.

“EU MDR will require companies [to] act before full clarity is available on what is required. Guidance and level setting will occur over time, but you cannot wait, and it is necessary to start with the requirements in the regulations and follow the intent of the requirements to guide actions,” Nancy Morrison, a regulatory vet told MassDevice.com.

“The level of clinical evidence required is growing even under the existing medical device directive and will continue to intensify with the EU MDR.”

A large number of companies don’t have a significant understanding of the changes, and over half have no strategy for tackling them, according to one consultant, who referenced a survey from the Regulatory Affairs Professionals Society (RAPS).

While acknowledging that the May 2020 deadline for the implementation of the new MDR is a “significant challenge,” the European Commissioner for Health and Food Safety said recently that the industry and government “are on course to meet it.”

However, a recent European Commission fact sheet cited decisions like ceasing the production of a product or being unable to get a product certified in instructing health care providers and health institutions to stock up on their most needed devices, warning that some devices may “become temporarily unavailable.”

CEO and Founder of UK-based MedBoard Ivan Perez told Focus that he met with a number of smaller companies and noted that the situation is “very concerning” as many appear to be in a “wait-and-see-mode.” “The level of action and readiness is very low, everybody seems to be ‘waiting’ or ‘holding’ for more information and certainty,” he said.

Cliff Notes

If this all seems overwhelming, Michelle McDonough, MS Director, Regulatory and Clinical Affairs and Mike Goodson, Associate Director, Regulatory Affairs from MCRA gave us the Cliff Notes of what you need to know.

• All MDD certificates will be considered valid after the date the MDR goes into effect (May 26, 2020) until they expire or until four years after the date the MDR goes into full effect (May 2024), whichever comes first.
• However, no significant changes are allowed during this period. A significant change is considered a change in the design and intended purpose as well as any change to the MDD certificate. For example, a change in the manufacturer’s address after May 26, 2020 is considered a significant change as it requires a change to the MDD certificate. It has been reported that NBs cannot legally issue any new or revised MDD certificates once the MDR is in full effect.
• Manufacturers still must comply with the MDR requirements related to post-market surveillance, vigilance, and registration of economic operators and devices
• Notified body back-log is forcing lengthy review periods and the review teams are giving little time for responses
• While there is an understanding that documents will need to be updated as industry learns the expectations, NBs are proving to be unforgiving if updates cannot be made extremely quickly, even when these documents were historically considered acceptable under the same NB’s review
• Some NBs have notified clients that they plan to cease operations due to the requirements under the MDR leaving some manufacturers without a NB in a time when NBs are stretched thin and not accepting new clients
• Company resources are stretched thin with ongoing MDD activities and updates to prepare for MDR. Company resources that were once adequate are proving to be insufficient
• Often this results in CERs not being updated to MEDDEV 2.7/1 Rev 4, delays in updating CERs, significant non-conformities from notified bodies, and often leaves too little time to make the necessary updates when needed
• These time constraints prior to audits results in CERs that are not sufficient
• CERs require weeks of extensive planning and updates, especially if they have not been updated to be Rev 4 compliant
• There is a tall learning curve for CER writers and the supporting cross-functional teams on the required inputs for a CER
• What was once sufficient is not anymore
• An evaluation of the clinical evidence will need to be performed as part of the process to ensure all device variants and indications are covered
• Where gaps exist, the Company will most likely need to initiate a PMCF study activity or the Company may consider (1) removing an indication from the labeling or (2) removing a device from the market
• Additionally, a review of the clinical evidence will need to be reviewed to assess if any new risks should be considered in the current risk documentation
• THESE THINGS TAKE TIME
• There is also the MDR requirement that all Class I reusable surgical instruments, which were devices that were self-certified under the MDD, will now need a CE certificate prior to May 2020 to remain on the market (e.g., Class I reusable surgical instruments)

The folks at EMERGO have provided a link to relevant documents.

Waiting Is Not an Option

Regulatory consultants we talked to all say the same thing: DON’T WAIT AND SEE. If you’re not ready, you are at risk of losing market share. Not surprisingly, they also say to call your device consultants.