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.
