Part 4 in our 7-part series on meeting the new requirements under the EU MDR
Complying with the European Union’s Medical Device Regulation (MDR) poses a daunting task for medical device makers marketing products inside the EU. One of the most taxing efforts for companies that already have CE-marked devices in the EU is the need for portfolio reviews.
Definitions and Reclassification
One of the first things device makers need to understand about the Regulation, according to BSI (British Standards Institute), is that there is no automatic acceptance of existing devices that are CE-marked under the existing Medical Device Directive (MDD).
The good news is that approximately 90 percent of devices are likely to remain the same classification, according to MD+DI News. The bad news is that even devices not reclassified may require additional supporting and technical documentations and new labeling, which may need to be reviewed by a Notified Body.
Consequently under MDR, you’ll need to review your existing products, including those that did not previously require approval under the MDD, as well as your pipeline to determine definitions and classification under the new Regulation.
Under new MDR definitions, some products previously excluded from the MDD will be defined as devices under the MDR. For example, products specifically used for cleaning, disinfecting, or sterilizing medical devices that were previously not covered under the MDD, now may be considered as devices depending on the process used.
Under the Regulation, chemical-based indicators of sterilization may be considered an accessory covered under medical device definitions, whereas biological-based indicators of sterilization may be excluded. The specific products redefined are listed in Annex XV of the Regulation.
In addition, classification rules will change for some devices currently on the market. Notable examples of such devices impacted by reclassification include substance-based medical devices such as nanotechnology devices, specific orthopedic implants such as spinal disk replacements, and re-useable surgical instruments, and even external devices such as Automated External Defibrillators (AEDs). A list of all the rules on classification of devices is spelled out in Chapter 5, Article 51 of MDR Annex VIII.
General Safety & Performance Requirements replace Essential Requirements
Another major change under the new MDR, is compliance with the General Safety and Performance Requirements, or GSPRs, that have replaced the Essential Requirements (ERs) under the MDD.
There are 23 GSPRs under Annex I of the MDR compared to 13 ERs in the MDD. BSI says the GSPRs that could have the greatest impact on device makers are requirements related to medicinal substances that are absorbed or locally dispersed, materials of biological origin, substances of concern, labeling, and cybersecurity.
Common Technical Specifications under the In Vitro Diagnostic (IVD) Medical Devices Directive are now replaced by Common Specifications and are included alongside harmonized standards under the MDR. They are incorporated in Article 9 of both the MDR and the IVDR.
The effect is that the EU Commission has authority to prepare a Common Specification in three situations: where no harmonized standards exist, where relevant harmonized standards are considered insufficient, or where there is a need to address public health concerns, according to the Johner Institute, a German regulatory training and education consultant.
Another added demand for device makers under MDR relates to the information supplied by manufacturers including labeling. Under Chapter III, Sect. 23 more details are required compared with the data needed under MDD. These details include unique device identification (UDI), the number and limitation of reprocessing cycles, identification of sterile packaging, and the availability of safety and clinical performance summary for class III devices and implantables.
Where appropriate the labeling should use symbols, for example icons used for irradiation sterilization. In addition, text for some icons is also required, such as “do not use if package is damaged.”
All such symbols need to conform to the harmonized standards. Where no such standard exists, the symbols must be explained in the documentation, including the Instructions for Use (IFUs). In addition, any information published in any medium (oral, written, printed, or electronic form) needs to comply with the specific product labeling.
Article 18 spells out the information manufacturers of implantable devices must provide to individual patients. The patient’s implant card must contain details of implant, including the UDI, device model, name and address of the maker, precautions, warnings to the patient and healthcare professionals, and device life expectancy.
All of these new requirements under the EU’s MDR pose significant challenges for device makers looking to enter or sustain business in the EU. Complying with the more stringent requirements for documentation, clinical evidence, labeling, data management, coding, and training will not come without substantial financial cost.
As part of your portfolio assessment and implementation plan, you’ll need to also consider the risks and benefits of obtaining CE marking under the MDR. You’ll need to make some strategic determinations around which products in your portfolio make sense economically to pursue CE Mark, and also consider other regions that use the CE mark for registration within the region.
The implementation and adoption process for entering or continuing to market your medical device products in the EU can be a formidable challenge. Kapstone Medical has the experience and expertise to help you every step of the way. Contact us for more information.