⚠️ Update: See below for important updates on EU-MDR compliance as of 2021.
- 13 Changes in the EU-MDR
- 2021 Update: EU-MDR Amended to Defer Date of Application
- Updated EU-MDR Timeline
- Schedule an EU-MDR Gap Assessment and Remediation Consultation
Europe's new Medical Devices Regulation (MDR) will bring significant regulatory changes that may impact multiple business units within your organization.
As companies plan and execute their transition projects to bring their organizations into compliance under the new Regulation, it's important to be aware of all the major changes that will require planning and action.
The video below is a snippet from our free webinar, The Complete Guide to EU-MDR Transition. In the full webinar, we highlight the key parts of the MDR, while going a step further to present a step-by-step MDR transition process that can be adapted to suit your company's unique needs. Watch the full webinar on-demand here and download the corresponding white paper here.
13 Key Changes in the EU-MDR
In the snippet below, Larry Stevens, RAC, offers a look into 13 important changes between the current Medical Device Directive (MDD) and the MDR. We've highlighted these 13 points in text below as well.
- The new regulation is four times longer, and contains five more annexes than its predecessor, the Medical Device Directive (MDD).
- The word "safety" appears 290 times in the MDR. The MDD, by comparison, uses it only 40 times.
- Significant changes in wording used in the new law will require companies to rationalize their portfolios and perform a global impact assessment in order to implement the necessary changes to remain compliant.
- Annex I, General Safety and Performance Requirements, identifies new conditions that will need to be addressed for most legacy devices (CE marked under the MDD). Existing products must be re-certified in accordance with the new regulations.
- The new rules will require most companies to update clinical data, technical documentation, and labeling.
- Unique Device Identification (UDI) will be implemented to help track devices throughout the economic operator supply chain and will be required on all labels.
- While the scope of the MDD did not encompass medical purpose devices and AIMD, these are both included under MDR.
- The definition of medical device will be broadened to include non-medical and cosmetic devices not previously regulated. Examples include products for cleaning, disinfection or sterilization of devices as well as contact lenses, liposuction equipment, or epilation lasers.
- Manufacturers will need to generate and provide more in-depth clinical data to prove safety and performance claims including tighter equivalency standards.
- Manufacturers will need to report all incidents, injuries and deaths into an EU portal that will centralize relevant data so that patients have access to more safety-related information. Reporting for incidents that did not result in death or serious deterioration in health is moved to 15 days from 30 days.
- Companies undergoing transition will need to revisit core processes including the quality assurance, risk management, and postmarket expectations. These will require careful review, planning and updating to re-implement in compliance with new requirements.
- Reclassification of many medical devices to a higher risk class and a new classification for reusable surgical devices requiring notified body oversight.
- IVDs are now classified into four risk classes that will require notified body review for about 90% of the devices, up from the current 10%.
2021 Update: EU-MDR Amended to Defer Date of Application
The state of the EU-MDR, at a glance:
- The date of application (DoA) of the EU Medical Devices Regulation (EU MDR) has been set back one year to May 26, 2021. Why? To "relieve pressure on national authorities, Notified
Bodies (NB), manufacturers, and other stakeholders, in light of the COVID-19 crisis."
- A March 2020 MedTech Summit report, which presented the results of a survey of manufacturers showed that:
- Only 17% of manufacturers felt fully prepared for the MDR.
- 15% reported being "not at all prepared" or slightly better.
- 65% of respondents were intending to use the full period of MDD/AIMDD certificates to get prepared the MDR.
The amending EU-MDR Regulation 2020/561 offers a wealth of detail impacted manufacturers should understand and act on now.
Here's a summary of the critical points:
- MDR Article 123.2 has been amended to read, as mentioned before, that MDR applies from May 26, 2021.
- MDD/AIMDD certificate transitional provisions: Notified Bodies may continue to issue certificates under MDD/AIMDD until May 2021. But the end of the grace period has not been changed. All MDD/AIMDD certificates still become void on May 27, 2024. Need expert assistance to stay on track with your original transition plan? Need help developing a transition plan? Get in touch with us to get expert assistance that is in extreme demand right now.
- Transition delays: Devices compliant with the MDD/AIMDD can continue being placed on the
market until May 26, 2024, so long as of May 26, 2021:
- the device continues to comply with either of the Directives, and
- there are no significant changes in the design and intended purpose of the product.
Note: With this delay, the requirements of the Regulation on Post-Market Surveillance, market surveillance, Periodic Safety Update Reports, and registration of economic operators and devices do not apply until May 26, 2021.
- EUDAMED confirmation pushed: The timeline for notice confirming EUDAMED is fully functioning has been pushed to March 25, 2021. While the database was originally delayed and re-slated for implementation in May of 2022 for both MDR and IVDR, it was only recently announced that modules will be available as they come online. The deployment of the actor registration module is now planned for March 2021. Moving forward from there, the modules for UDI/device registration and certificates/NBs should be available by May 2021.
- New amendment on derogations: A new amendment adds an important provision for facilitating derogations from conformity assessment procedures across the EU. With COVID-19, this may enable certain devices to be made available in emergencies despite not having gone through through a full conformity assessment.
- Notified Body designation: While the European Commission originally predicted there would be 20 MDR-designated Notified Bodies by the start of 2020, as of February 11, 2021, there are 18. See the full list on Commission's official database here. Four Notified Bodies are currently designated for the IVDR. See that list here. At the end of 2020, the Commission stated that 90% of current MDD Notified Bodies were seeking designation. Progress is being slowed by the COVID-19 pandemic as on-site audits are required to proceed to the final stage of designation.
- Notified Body audits: The pandemic has hindered on-site Notified Body audits. Recent guidance from the Medical Devices Coordination Group (MDCG) sought to address this problem by presenting "temporary alternative extraordinary measures." These include the following "principles and arrangements":
- "Postponement of on-site surveillance audits under the Directives in line with documented procedures of the notified body for force majeure."
- "On-site audits may be replaced by remote audits using the most advanced available Information and Communication Technologies as appropriate in accordance with legislation on information security and data protection."
- "Assessment of all relevant and required documents/records off-site by the
- "To take into account existing recent results from MDSAP audits (or other
appropriate audits) in lieu of Directive audits, where available"
- To consider published international guidance such as those issued by the International Accreditation Forum (IAF) e.g. on how to use information and communication technologies [citation] and for alternative auditing methods in extraordinary circumstances [citation]."
Note that the scope of these measures is limited to the following:
- Audits conducted for re-certification purposes under the medical devices Directives
- Surveillance audits under the medical devices Directives
- In situations where a manufacturer submits a change notification to a Notified Body that would typically require on-site audit or verification
- In cases where a manufacturer terminates (voluntarily or involuntarily) its contract with a Notified Body and enters into a contract with another notified body in respect of the conformity assessment of the same product(s)
Updated EU-MDR Timeline (February 2021)
|Article||Article Title||Original Date (MDR 2017/745)||Amended Date (2020/561)|
|123.2||Entry into force and date of application||26 May 2020||26 May 2021|
|120.1||Last day Notified Bodies can issue MDD/AIMDD certificates||25 May 2020||25 May 2021|
|120.2||Day on which all MDD/AIMDD certificates become void||26 May 2024||26 May 2024 (Unchanged)|
|120.3||Day on which delay for transitional provisions of MDR on PMS, and registration of economic operators and
products for all devices to take effect
|26 May 2020||26 May 2021|
|120.4||Day on which the sell-off period ends||26 May 2025||26 May 2025|
⚠️ Important EU-MDR Action Items for Impacted Manufacturers in 2021
Notified Bodies are under pressure to re-certify existing products under the current directives before the MDR arrives in May of 2021. As we wait to see whether a potential expansion of remote audits comes to pass, it's incumbent on manufacturers to ensure they're fully prepared for whatever kind of assessment process they receive.
- In the short term, all manufacturers relying on extending their MDD certificates before May 2021 should develop and to the extent possible, execute a planned strategy with timings established.
- In the long term, manufacturers need to establish the timetable for their Notified Body transition to MDR designation if it has not been designated already and plan to avoid a bottleneck.
- In addition to revising technical documentation, manufacturers will also likely need to:
- Revise Standard Operational Procedures (SOPs) around the quality management system (QMS).
- Implement and train on new SOPs to ensure you have auditable records in place before the Notified Body audit.
Join other medical device companies preparing for EU-MDR transition with The FDA Group.
Need to conduct critical gap assessments and subsequent quality system remediation in preparation for the EU-MDR, either on-site or remote? It's not too late to schedule support engagements with experienced EU-MDR experts who have helped other organizations successfully assess their state of readiness and take the necessary steps to ensure full conformity. Contact us today and get the conversation started.
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Contact us to learn more about our EU-MDR support capabilities and find the expert support you need—when and where you need it—to ensure you're fully prepared for fast-approaching deadlines.
FREE WHITE PAPER
The Complete Guide to EU-MDR Transition
In this in-depth guide, you'll learn some of the major elements of this new Regulation that will likely require action on the part of regulated companies. We also present a process for transition that can be adapted to suit your organization’s specific needs.