With the looming deadline for compliance with the EU Medical Devices Regulation (MDR), device manufacturers face a host of questions about how to prepare their existing products for compliance. In this post, we provide answers to top questions about EU MDR compliance.
Is it possible to avoid compliance with the EU MDR?
The short answer is no. Manufacturers who intend to market their medical device in the EU Member States must be compliant with the EU MDR. Manufacturers who have existing products on the market must also be compliant. There are no grandfathering provisions with the regulation, and all currently approved devices must be re-certified in accordance with the new requirements.
When do manufacturers need to recertify?
The EU MDR went into force on May 25, 2017. For existing products, manufacturers have the option of recertifying MDD certifications that are about to expire to buy some time for compliance with the EU MDR. Re-certification under MDD will enable manufacturers to keep their products on the market until May 2024 or the recertification expiration date, whichever comes sooner. However, manufacturers should keep in mind that their ability to recertify under MDD is dependent on certain circumstances related to their current MDD standing, including the absence of gaps in their compliance activities.
Manufacturers who intend to bring a new product into the EU market on or after May 25, 2020, must be compliant with the EU MDR by that date.
Which products are affected?
Under the EU MDR, the definition of a medical device is any instrument, apparatus, appliance, software, implant, reagent, material, or other article intended to be used for any of the following medical purposes:
- Diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease
- Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability
- Investigation, replacement, or modification or the anatomy or of a physiological or pathological process or state
- Providing data via in vitro examination of samples derived from a human body
- Cleaning, disinfection, or sterilization of medical devices and devices for control or support of conception
The inclusion of devices that do not have medical-intended purposes and devices designed for the purpose of prediction of a disease or health condition represents a notable expansion of the previous definition of medical devices.
Will the products need to be reclassified?
The EU MDR reclassifies devices according to four risk classes, where risk is defined as the probability of occurrence of harm and the severity of that harm. Manufacturers are advised to review the updated classification rules and update their technical documentation accordingly.
Are systematic clinical evaluations required?
Regulations around systematic clinical evaluation of Class IIa and IIb medical devices have become more robust within the EU MDR. Manufacturers will need to prepare the clinical evaluation by considering the new wording in the regulations regarding when an equivalence approach is acceptable and under which circumstances it is possible to justify not conducting a clinical investigation.
The EU MDR is also more rigorous with regard to the provision of clinical evidence for Class III and implantable medical devices. In cases where they do not have sufficient clinical evidence to support claims of both the safety and performance of a particular device, manufacturers will need to conduct clinical investigations.
What about labeling?
Under the EU MDR, Class I devices — particularly reusable medical devices — must be labeled with the number of a Notified Body. As current labels will no longer be acceptable, manufacturers should consider how changes to labeling will impact the process of getting finished products to market.
Has post-marketing surveillance changed?
With the updated regulation, products are subject to more rigorous surveillance by Notified Bodies.
How will Brexit affect manufacturers?
The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has indicated that it intends to follow the May 25, 2020 transition of the EU MDR. In February 2019, the MHRA also published a new guidance on regulation of medical devices in the event of a no-deal scenario.
If you have more questions, contact us here to reach a Premier expert directly.