As the new European Medical Device Regulation took effect on 26 May 2021 to replace the previous Medical Device Directive (93/42/EEC), it’s time to revisit what EU MDR means for medical device developers. Read on to learn if EU MDR applies to your products, and what changes you’ll need to prepare for if you haven’t already.
What’s the timeline for EU MDR taking effect?
The new European Medical Device Regulation was formally published back in May 2017, entering into force and kicking off a 3-year transition period.
If the legislation applies to any of your products that you’re looking to place on the European market (see more on the scope of the regulation below), you’ll have to ensure compliance with its requirements by spring 2020. Compliance certifications issued until 26 May 2020 will remain valid for 5 years. So any product that was put on the EU market (with all necessary certifications cleared) can be legally sold in the EU even after MDR takes effect – however, all compliance certificates will become void on 25 May 2024.
UPDATE April 2020: Due to the COVID-19 outbreak, the European Commission announced a proposal on 25 Mar 2020 to postpone the application date of the Medical Devices Regulation (MDR), extending the deadline with one year. In April 2020, Regulation (EU) 2020/561 was published in the Official Journal of the European Union, updating the date of application from 26 May 2020 to 26 May 2021.
Scope of EU MDR: Are you affected?
Upon replacing previous regulations, regulatory bodies extended the scope of this new Medical Device Regulation to cover a broad range of products, even some non-medical purpose products.
As a developer of healthcare or aesthetic products (whether or not they are currently exempt of regulations), it’s crucial to assess whether your line of products will be affected, since EU MDR’s scope extends to non strictly medical products such as condoms, contact lenses, or lasers for tattoo or hair removal.
EU MDR doesn’t differentiate between types of software with a medical purpose – instead, both embedded and standalone software (“software that drives a device or influences the use of a device”) are covered by the new regulation.
The text defines a medical device as any “instrument, apparatus, appliance, software, implant, reagent, material, or other article” that is intended to be used for:
- the diagnosis, prevention, monitoring, treatment or alleviation of disease, disability, or injury
- the investigation, replacement, or modification of an anatomical, physiological, or pathological process
- providing data based on samples derived from a human body (via in vitro examination).
In addition, EU MDR also applies to any device used for the control and support of conception, and all products used for the cleaning, disinfection, and sterilization of medical devices.
Key changes in EU MDR
So in case your products are affected by changing regulations, what should you prepare for?
EU MDR brings some significant changes compared to current MDD regulations. Overall, in line with US and international regulations, EU MDR requires that developers of medical products shift to a lifecycle approach using a comprehensive Quality Management System.
They will need to rethink their approach to core processes like QA, risk management, and post-market product surveillance. EU MDR requires that developers ensure a focus on quality, risk management, and usability throughout the entire lifecycle of the product (with a lot more emphasis on post-market clinical followup).
Let’s see what specific changes EU MDR means for product developers:
EU MDR requires manufacturers of medical devices to appoint at least one person in the organization that’s going to be responsible for achieving compliance with the new regulation. In identifying this person, the organization will also have to document the qualifications of this quality representative.
The new regulation brings increased scrutiny for the assessment of high-risk devices by an independent body of regulatory experts. For one, the required scope and depth of risk management activities is changing from “as far as is reasonably practical” to “as far as possible”. Whenever developers encounter risks where they are not able to do that, those risks may have to be displayed on the label (or in the instructions manual).
Unique Device Identification (UDI)
The regulation extends downstream traceability across the supply chain through the use of UDI mechanisms. UDI aims to enable both manufacturers and authorities to trace specific devices even after they get to the market, making it easier to identify and recall certain products if necessary. It will also help EU authorities set up a comprehensive EU database of medical devices on the EU market.
The requirements around using UDI tie in with the next significant change in EU MDR:
With EU MDR, Notified Bodies get more authority around post-market surveillance: unannounced audits and wider options around product testing makes it easier for them to reduce the risks of medical devices already on the market. In some cases, medtech developers will be required to report annually on the safety and performance of their products.
Reclassification, more rigorous clinical evidence
Some device manufacturers may have to reclassify and recertify certain products (specifically, class III and implantable devices) based on the new regulation’s higher scrutiny on risks and safety.
With new products, they may be required to conduct clinical investigations, and they’ll have to collect and manage post-market clinical data to enable ongoing safety assessment.
Changes around how EU MDR treats device equivalence mean that a manufacturer will have to have access (by contract) to all the technical documentation of the equivalent device used to simplify the certification of the new product. What this means in practice is that “grandfathering” (using existing data on an equivalent device) will become more difficult, prompting developers to rationalize their product portfolios.
Overall, EU MDR necessitates that developers of medical products implement deep-rooted changes in the way they operate on the EU market. From the revision of their QMS processes and activities to changes around labeling, preparing for EU MDR is a significant transformation for the organization.
Wondering what exactly EU MDR requires from medical device developers, and how it affects your organization? Download our guide by independent MedTech consultants for an analysis of the implications of EU MDR and a recommended approach & best practices for compliance!