Europe to Issue New Safety Regulations for Medical Devices and Diagnostics: What You Need to Know

Want to find a place in the EU market for your IVD/med device? You’ll need to get through some new hoops first!

As the first quarter of 2017 drew to a close, the in vitro diagnostic (IVD) and medical device markets in Europe faced the advent of new regulations designed to improve post-market surveillance, traceability, and safety of high-risk devices.

Originally proposed five years ago, these regulations will take effect in three years (2020) for medical devices and five years for IVDs (2022).

The passage of new rules comes at a time when U.S. manufacturers of laboratory-developed tests (LDTs) are trying to penetrate the EU market with a variety of cancer-focused diagnostics.

Kalorama Information identifies this trend as an “emerging dynamic and a top five IVD trend of 2017” due to the stability of the region’s regulatory management, favorable economic conditions, and demand for advanced LDT services.

According to Kalorama’s recent whitepaper on IVD trends, three notable companies are forging a path into the EU market: Myriad Genetics, Genomic Health, and Foundation Medicine.

As these companies grow their LDT offering in Europe, they will also have to get comfortable with the new regulations set out to govern IVDs and medical devices from 2020 onward.

Let’s take a quick look at the major regulatory changes that have been introduced:

• Improved protection of patient health and safety – High-risk devices will be subject to stricter pre-market control that encompasses rigorous clinical evaluation and performance studies. According to the announcement by the European Commission, this includes colored contact lenses or liposuction devices. The new directive will mandate the assessment of 4 out of 5 IVD devices by a notified body before they are allowed on the market (current regulation: only 1 in 5 devices need to be checked).
• A comprehensive medical device database for the EU – Dubbed EUDAMED, this database will document the entire life cycle of every product in the EU market, with real-time updates. And yes, most of the information will be publicly available after the European Commission sets up the database in 2020.
• A new device identification system and an ‘implant card’ for patients – Triggered by the PIP breast implant scandal, this rule was added to provide simple traceability and easy access to device information for patients. Devices will be tracked by a unique device identifier (UDI) and patients will be given an implant card which can be used to access important device information via a publicly accessible database.
• A new financial mechanism to ensure compensation – This regulation requires effective measures to be put in place by manufacturers for financial coverage in the event that a patient is harmed by a defective product. Financial compensation will be proportionate to the risk class, type of device, and the size of the enterprise.

The European Commission recently confirmed that these rules will not only affect all medical devices, IVDs, and their accessories, but also aesthetic products like the aforementioned contact lenses (because such devices require the same level of safety as existing medical devices).

These diagnostics and devices are considered under four risk categories when evaluating conformity, and risk category will affect overall assessment; products in the high-risk class, for example, will undergo a tough assessment procedure conducted by a Notified Body, which is essentially an independent third party.

European leaders believe the new device regulations will result in simplified administrative procedures, increased legal certainty, and credibility of the overall system.

Manufacturers from all over the world (and especially the U.S. LDT developers aiming to cross the pond) will have to keep a watchful eye on how the European Commission rolls out changes and creates a (hopefully) smooth implementation.