9 Key Changes Introduced by the EU Medical Device Regulation (MDR) 2017/745
by Breda Kearney | October 21, 2020 | Blog , EU MDR , EU Medical Device Regulation (MDR) , Medical Device Regulatory Affairs , Regulatory Affairs , |
The medical device sector is highly regulated due to the risk to patient safety, including serious illness or death, which is posed by defective medical devices and/or devices that do not perform as intended. In Europe, medical devices are regulated by the Medical Devices Directive (MDD) 93/42/EEC and the Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC.
However, in recent years, several high-profile medical device scandals including the PIP breast implant scandal and the metal-on-metal hip implant scandal raised concerns regarding the suitability of the directives for protecting public safety. Additionally, despite several amendments, the directives have failed to keep pace with the rapid advances in technology and medical science, such as the use of software applications for medical diagnosis.
In response, the European Commission recognised the need to overhaul the medical device regulatory framework. In 2012, this resulted in the publication of an initial draft of a new regulation: EU-Medical Device Regulation 2017/745 (MDR) to repeal and replace both the MDD and AIMDD. The regulations were adopted by the Council and Parliament in April 2017 and came into force on May 26th, 2017. This signaled the start of a transition period: Initially manufacturers were provided 3 years (May 2020) to transition from the directives to the MDR, however due to COVID-19 the transition period has been extended to May 2021. In this article we will review some of the key changes introduced by the MDR.
1. Regulations v Directives
The MDR is a “Regulation” whereas its predecessors MDD and AIMDD are “Directives”: This is an important distinction and has a significant impact on implementation of the new regulation. Directives are adopted by each EU member state, meaning that each member state can determine how best to implement the directives into national law. In the case of the MDD and AIMDD this resulted in inconsistency in medical device regulation across the EU. By contrast, as the MDR is a “Regulation”, it directly applies to each EU member state without modification. Therefore, the member states cannot make any amendments and this change should ensure the consistent regulation of medical devices within the EU.
2. Medical Devices and Classification
The scope of the MDR has been expanded to include products that do not have an intended medical purpose but carry similar risks to a medical device. These devices are listed under Annex XVI and include products such as fashion contact lenses, sunbeds and liposuction equipment. In addition, devices that are used for cleaning, sterilization and disinfection, such as autoclaves and contact lens cleaning solutions, are now considered to be medical devices in their own right and fall under the scope of the MDR.
The MDR has 22 rules for classifying a medical device; an increase of 4 rules compared to its predecessor. These rules must be read carefully by the manufacturer as they may result in a classification change for some devices. The MDR also introduces a new classification, Class Ir, for reusable surgical devices. Unlike other Class I devices, Class Ir devices require notified body involvement.
Acknowledging the advances in the development and use of software for activities such as patient monitoring, the MDR has introduced rule 11 which is specifically used for the classification of software dependent on its intended use.
3. Unique Device Identification (UDI)
The UDI is a unique code that will be applied to all medical devices, including their labelling and packaging. The purpose of the UDI is to ensure that each medical device is fully traceable from the manufacturer through to the final user, thereby facilitating the rapid and effective recall of any defective products from the market. In addition, the manufacturer must ensure that information about the medical device is entered to the UDI database on EUDAMED
The timelines for applying the UDI are as follows:
Source: EC Unique Device Identification System – FAQs: https://ec.europa.eu/docsroom/documents/42641?locale=en
4. Person Responsible for Regulatory Compliance (PRRC)
The PRRC is a new role introduced under article 15 of the MDR. The PRRC is employed by either the manufacturer or the authorised representative (appointed by manufacturers based outside of the EU) and has very specific responsibilities. These responsibilities include ensuring that unacceptable or defective devices are not released to the market and that post market surveillance and vigilance reporting requirements are fulfilled. The MDR imposes strict educational and experience requirements for the PRRC, which isn’t surprising given the important role played by the PRRC in safeguarding regulatory compliance.
5. Compensation for Injury or Harm Caused by Defective Devices
The manufacturer must have sufficient liability insurance to financially compensate anyone that is injured or harmed by a defective device. In the case of manufacturers based outside of the EU, the authorised representative will also be held jointly liable for any injury caused by a defective device. This joint liability may result in authorised representatives taking a more cautious approach when selecting which manufacturers, they represent in the EU and terminating their agreements if there are any quality or safety concerns.
6. Life-Cycle Regulatory Approach
The focus of the MDD/AIMDD was regulation of the pre-approval stages of the medical device. However, in line with the US FDA, the MDR has adopted a full life cycle approach. This change means that the manufacturer is responsible for ensuing the safety and performance of the medical device from initial design through to device end-of-life. This change places more stringent data collection, analysis and reporting requirements on the manufacturer.
The manufacturer must plan for, and collect, data and information about the safety and performance of its devices using a combination of proactive and reactive methods. Examples of proactive methods include reviewing device registries, focus/expert groups, attending conferences. Examples of reactive methods include: analysing customer complaints, The findings and any resulting actions must be documented in the Post Market Surveillance (PMS) report (Class I) or periodic safety update report (Class IIa/IIb/III) and used to update the technical documentation including the risk-benefit determination. The reports must also be provided to the competent authority on request. Also, the data and information derived from the PMS activities must be entered on EUDAMED
7. Clinical Evaluation
Prior to placing a device on the market, the manufacturer must demonstrate that it is safe and performs as intended in accordance with the General Safety and Performance Requirements outlined in Annex I of the MDR. This is achieved by conducting a clinical investigation and/or demonstrating equivalence to a similar device. Under the MDR the criteria for demonstrating equivalence is more stringent compared to the MDD/AIMDD, meaning that it will be difficult for manufactures to rely solely on the equivalence approach.
The impact of this change is that there will be more of an onus on manufactures to conduct clinical investigations to demonstrate compliance to Annex I. Its important to note, that for legacy devices, manufacturers must conduct a comprehensive gap assessment against Annex I and identify if there are any gaps in the clinical data for their device which may prevent re-certification. Under the MDR, manufacturers must also conduct post-market clinical follow-up (PMCF) and using the data collected, update the clinical evaluation for the device. The data and information derived from the PMCF must also be entered on EUDAMED.
8. Notified Body Scrutiny and Unannounced Audits
Notified bodies (NB) play a critical role in ensuring that only safe medical devices that perform as intended are approved for use in the EU. Under the MDR, NBs face greater scrutiny and oversight particularly in relation to their assessment of high-risk devices. For example, in the case of class III implantable devices, the NB must submit (1) the manufacturers clinical evaluation and (2) the NBs own assessment of the clinical evaluation to an expert panel for review. The expert panel will decide on whether to issue an opinion. If no opinion is issued, the NB can certify the device. If an opinion is issued, the NB must consider the expert panels views. If they decide not to follow the advice, they must issue a publicly available justification. NBs are also required to conduct unannounced audits, product testing and to sample and analyse medical devices from the market to verify compliance to the MDR.
NBs that are currently designated under the directives, must apply for a new designation under the MDR. However, several NBs have taken the decision not to pursue designation under the MDR. This could be due to challenges in recruiting suitably competent personnel or resourcing the additional workload that has resulted from the MDR.
9. CE Marked Devices
Currently there are thousands of CE marked medical devices on the EU market which are regulated under the directives. One of the most important steps in the CE marking process is demonstration of compliance to the Essential Requirements (ER), which are used to demonstrate that the device is safe and performs as intended. Under the MDR, the ER are replaced by the General Safety and Performance Requirements (GSPRs). While the GSPR are for the most part equivalent to the ER, the GSPRs contain additional and more stringent requirements. This means that all legacy devices must be reassessed to demonstrate compliance with the MDR – in essence, undergoing a new CE marking process. It’s important to note that failure to demonstrate compliance before the end of the transition period will result in loss of CE marking and removal from the EU market.
In this article, we provided a brief overview of the key changes introduced by the MDR. However, it is important to note that the MDR is a large and complex document and includes additional changes, outside of the scope of this article. Its essential that not only the legal manufacturer but all roles involved in the supply chain, clearly understand the requirements of the MDR and the implications for their organizations. While the transition to the MDR has been delayed to May 2021, organizations must not underestimate the amount of work and additional resources that are required to address the new and enhanced requirements, particularly as the additional clinical data requirements are expected to pose a challenge to many medical device manufacturers.
If you are interested in learning more about the EU Medical Device Regulation (MDR 2017/745), Comply Guru offer two online & self-paced courses: