With the clock winding down, what does this new Medical Device Regulation (MDR) mean for you if you have previously approved devices or if you’re looking to bring new products to market?
As a medical device manufacturer distributing in the European Union (EU), the clock is ticking for you to transition from the decades-old Medical Device Directive (MDD) to the new MDR. The MDR came into force in May 2017 and provided a transition period for manufacturers of currently approved medical devices. You have until May of 2020 to fully transition over.
To help you prepare, we’ll answer some of the commonly asked questions about the EU Medical Device regulation timeline below.
What You Should Know About the EU Medical Device Regulation Timeline
If you fail to transition to the new MDR before the May 2020 deadline, your business will be set back. You’ll be unable to import or export your products. Also, since many of the EU countries have centralized health care systems, your products will not be able to be sold or used anywhere until you resolve the issue with your Notified Body.
Don’t risk your company’s well-being. Follow the regulations and get transitioned before the deadline.
The Transition Timeline is Ending Soon — Are You Ready?
The Medical Device Regulation (MDR) is replacing the EU’s current MDD (93/42/EEC) as well as the EU’s Directive regarding active implantable medical devices (90/385/EEC). The MDR came into force on May 25, 2017 and gives manufacturers of currently approved medical devices until May 25, 2020 to meet the new requirements.
Medical device manufacturing is already a complex process, so it’s no surprise that making this transition is a complicated and time-consuming requirement for most manufacturers. Because of the complexity, you are advised to stay current on the progress of the MDR.
Preparation and early action are the keys to ensuring a smooth transition. It’s expected that a large number of medical devices will require Notified Body review. This can result in delays reviewing and certifying products that you will need to anticipate. You should consult with your respective Notified Body to plan for potential quality or compliance issues and build a plan to address them quickly.
Any Class 1 reusable medical devices placed on the market after May 25, 2020 are required to be in compliance with the MDR. They must also be labeled with the number of the Notified Body starting May 25, 2020.
In general, any devices that were placed on the market lawfully under the current MDD/AIMDD and placed before May 25, 2020 can be made available and used until May 25, 2025.
Do You Qualify for Legacy Exemptions?
If your device was currently approved, you have until May 26, 2020 to transition to MDR. However, certain devices can request an extension until May 26, 2024 — but special requirements must be met to grant the extension. You will want to work with your Notified Body to determine if you meet those requirements.
Obtaining New CE Marks Takes Time
The old MDD served almost like a manual for how a medical device company could get their CE mark and launch their product. The new MDR is different. It has new regulations that encourage procedures and policies designed to elevate your responsibilities for your products throughout the product lifecycle.
The MDR also clearly specifies which types of products will need to obtain their CE marking — including products designed to disinfect, clean, or sterilize devices and devices used to control or support conception.
After you apply for a CE, the wait time is typically between 12 and 16 weeks. However, most Notified Bodies offer options for expedited reviews or even on-site review of your Design Dossier and Technical Files.
Differences Between the Old MDD and the New MDR
The new MDR is different from the MDD in several important areas.
The definition of “medical device” has been expanded.
The new definition covers many more devices — including ones that may not have originally had a medical purpose. This includes things such as colored contact lenses, cosmetic devices, and devices for the purpose of “prediction and prognosis” of diseases and health conditions.
You are required to provide a “qualified person.”
Your company will have to identify at least one person within your organization that is ultimately responsible for all aspects of MDR compliance. This requirement also stipulates that you have to document the qualifications of this individual as they pertain to the required tasks.
The MDR implements more detailed tracking mechanisms.
The new guidelines require the use of unique device identification (UDI) mechanisms that allow manufacturers and authorities to trace individual devices through their supply chain. This is intended to make recalls fast and efficient if the devices have been deemed a safety risk. Additionally, it’s expected that the European Databank on Medical Devices (Eudamed) will be expanded to allow more efficient access to information about medical devices that have been approved.
Notified Bodies are granted greater authority in post-market surveillance.
Your Notified Bodies will now have the ability to perform unannounced audits that include product sample checks and product testing. This is intended to strengthen the EU’s ability to enforce its regulations and reduce the risk of unsafe devices being on the market. Many manufacturers will also be required to submit annual safety and performance reports.
The EU Commission or expert panels can publish Common Specifications.
Common Specifications will be expected to be taken into account by you and your Notified Bodies. These specifications will be put in place alongside the Harmonized Standards and the State of the Art.
You will have to update your Technical Documentation to meet higher requirements.
The MDR will require you to review updated classification rules and update your technical documentation accordingly. Your documentation should reflect the fact that Class III and implantable devices will have higher clinical requirements and a regular scrutiny process.
You will need to conduct clinical investigations if your clinical evidence is lacking.
If you do not have sufficient clinical evidence to support your claims on both performance and safety on your dedicated devices, then you will be required to perform clinical investigations. You will also have to collect and retain post-market data as part of your ongoing potential safety risk assessment.
Clinical evaluations will need to be re-prepared.
You will need to consider the new wording of the regulations for Class IIa and Class IIb medical devices regarding an equivalence approach and when it’s possible to justify not performing a clinical investigation. This information will help you re-prepare your clinical evaluations.
There are no exceptions at this time.
Currently, under the MDR there are no “grandfathering” provisions for existing devices. All currently approved devices will be required to be re-certified following the new requirements. Even though there are no current exceptions, there are exceptions currently being negotiated that might apply in the future.
Quality Management is Paramount
Under the MDR, your quality management systems will be regulated with more scrutiny than ever before. Organizations that use an effective quality management system (QMS) have the ability to catalog, review, and act on every aspect of the product lifecycle.
Learn how to use a QMS to implement a culture of quality and apply it across all of your product development efforts. Download your free ebook: 7 Things You Can Do Now to Improve Quality in Medical Device Product Development.