In May 2021 the Medical Device Directive (MDD) and the Active Implantable Medical Devices (AIMD) will be replaced by the Medical Device Regulation (MDR) in the EU. What does this mean and what do medical device companies and others need to consider?
The reason behind the new medical devices regulation (2017/745/EU), MDR, is to bring EU legislation into line with current technical advances, changes in medical science and progress in law making. Another underlying reason is to increase patient safety by reducing the risk of incidents were medical devices have caused patient damage.
“Also, in contrast to directives, regulations do not need to be transposed into national law,” explains Helena Dahlin, Director Regulatory at Key2Compliance. ”This will reduce the risk of discrepancies in interpretation across the EU market.”
Novel features of the MDR are emphasis on a life-cycle management to improve safety, by higher demand of clinical data on the specific device, and an increased role for the notified bodies, which means there will be more stringent requirements for the designation, says Maria Lindgren, Director Clinical Development at Key2Compliance.
“The MDR also reclassifies certain devices and has a wider scope, for example it covers all devices for cleaning, sterilizing or disinfecting other medical devices, reprocessed single-use medical devices and certain devices with no intended medical purpose (Annex XVI),” she adds. “Also, internet sales (devices and services) fall under the scope of the regulation and there will be a new unique device identification system, which means an improved traceability and the effectiveness of post-market safety-related activities.”
Maria Lindgren and Helena Dahlin also mention that the obligations of different actors and their relations are now more clearly stated, and there should also be a person responsible for regulatory compliance available.
“The MDR also requires an increased transparency, information on devices and that information being made public is available.”
“For Class IIb devices and for implantable Class III devices, a consultation procedure by an independent expert panel reviewing the clinical development of the device is planned. The MDR also requires an increased transparency, information on devices and that information being made public is available,” says Dahlin.
Check your product portfolios
So, May 2021 is getting closer, what do different life science actors need to consider? First of all, when it comes to medical device companies, manufacturers, authorized representatives and importers they all need to register when placing their devices on the market or putting them into service.
“Manufacturers must also ensure that their devices have been designed and manufactured in accordance with the new requirements. Check your product portfolios to find out whether your devices fall within the scope of the regulation. Also, make sure that your current risk classification is valid, some devices will be reclassified and this will have implications on the CE-mark,” advices Dahlin.
Manufacturers need to handle clinical evaluation, risk management, quality management system, post-market surveillance, liability for defective devices and technical documentation. Manufacturers of some implantable devices might also have to provide an implant card for the patient.
Distributors and importers need to co-operate with manufacturers or authorized representatives to achieve an appropriate level of traceability of devices, continues Dahlin.
“Importers should only place devices on the market that are in conformity with MDR. They need to check that the devices are CE-marked, that an EU declaration of conformity is drawn up, that labelling is according to MDR, and that the Unique Device Identification (UDI), if applicable, is assigned,” Dahlin explains.
Name and trade name, registered place of business and the address at which they can be contacted need to be on the label, and they need to ensure that any additional label does not obscure any information on the label provided by the manufacturer. Importers also need to ensure that, while a device is under their responsibility, that storage or transport conditions do not jeopardize its compliance set out by the manufacturers.
“When receiving complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device which they have placed on the market they must immediately forward this information to the manufacturer and its authorized representative,” says Lindgren.
Medical device software
Software (defined as a set of instructions that processes input data and creates output data) now falls under classification Rule 11 in the MDR. However, not all software used within healthcare is qualified as a medical device, Lindgren and Dahlin emphasize.
“Many medical device software (MDSW) will be re-classified, leading to that these products will need the involvement of a notified body.”
“Many medical device software (MDSW) will be re-classified, leading to that these products will need the involvement of a notified body. For all MDSW, the manufacturer should ensure safety and performance throughout the lifecycle, through a continuous process of clinical and/or performance evaluation and risk management,” says Dahlin.
Software for which the manufacturer claims a specific medical intended purpose, i.e. the software has a clinical benefit, needs to have clinical evidence within its own conformity assessment.
“You also need to consider cybersecurity requirements (listed in Annex I General Safety and performance) of the MDR, which deals with both premarket and post-market aspects. Privacy and confidentiality of data associated with the use of MDSWs that may be outside the scope of the MDR are subject to other legislation,” explains Dahlin.
Finally, we asked Maria Lindgren and Helena Dahlin to share their best advice to companies affected by the new regulation, and they highlighted a few important take-away messages.
“Regulatory requirements concerning your products and your quality system must both be included.”
“State which requirements apply to your device and follow a plan to fulfill them. Regulatory requirements concerning your products and your quality system must both be included. Also, consider important timings and the workload of notified bodies, and remember that it takes time to collect clinical data,” says Lindgren.
“It is also important to prepare your organization for the changes, empower and train your staff, and do not forget the liability aspects for defective devices. Finally, keep an eye on the range of guidance documents on the European Commission’s website,” adds Dahlin.