Caroline Freeman, Senior Consultant, Quality & Compliance Services, IQVIA
With less than 2 months to go to the date of application of the EU Medical Devices Regulation 2017/745 (MDR), set for May 26, 2020, the Commission finally announced on March 25, 20201 that work is ongoing to postpone this by one year. The announcement was quickly followed by the publication of the Commission proposal text on April 3, 20202, and this was followed within three working days by the Council’s own document establishing the mandate for negotiating with the European Parliament, and also, incidentally, making a much-needed technical correction to the original Commission proposal3. Political agreement from the European Parliament (EP) was reached in a vote in plenary session by an overwhelming majority of EP members, on April 16, 2020. The EP dealt with the proposal as an urgent procedure and made no additional changes to the Council’s text.
There are a few remaining steps in the full legislative procedure, but it is not expected that the proposal can be derailed at this stage. There is therefore every expectation that the text of the Amending Regulation will be published in the EU Official Journal at the end of April, and applied before May 26, 2020. The reason given for the proposal is to relieve pressure on national authorities, Notified Bodies (NB), manufacturers, and other stakeholders, and allow them to fully focus on urgent priorities related to the COVID-19 crisis.
This is welcome news for all involved. For a long time, MedTech Europe, together with other trade bodies around the world, had been advocating a delay due to the shortage of MDR-designated NB, lack of required guidance and implementing acts, and absence of Eudamed. Earlier the same week of the original Commission announcement, MedTech Europe had issued a press release requesting a delay until six months after the end of the COVID-19 crisis4. Undoubtedly, the impact of COVID-19 on NB’s ability to complete on-site audits under the Directives and/or MDR, as well as the pandemic’s more general impact on availability of manufacturer and NB staff due to illness or working from home, combined with the need for certain manufacturers to focus on increased output of equipment (e.g. ventilators), have compounded to make inevitable the decision to push the proposal through.
The amending proposal is very detailed, and it is relevant and interesting to read the preamble statements (12 in total) to fully appreciate the intent of the proposal. A summary of the key points of the text appears below. A more detailed clause-by-clause analysis is available by contacting IQVIA.
MDR to apply from May 26, 2021
There are some inconsistencies within the Commission’s proposal requiring further clarification. The key “error” has already been spotted and addressed in the Council’s document. For the real details of the delay in the date of application (DoA), go directly to the end of the proposal, where MDR Article 123.2 is amended to read that MDR applies from May 26, 2021.
Probably the next most important section is Article 120 on transitional provisions. Article 120.1 is amended such that NBs may continue to issue certificates under MDD/AIMDD5 until May 2021. Article 120.2 on the end of the grace period is unchanged, such that all MDD/AIMDD certificates become void on May 27, 2024. One might have expected this date to be extended also.
Key transition provisions delayed
In Article 120.3, the key paragraph on transitional provisions has now also been changed such that devices that comply with the MDD/AIMDD can continue to be placed on the market or put into service until May 26, 2024, provided that from 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. (The Commission text originally caused confusion by not amending this occurrence of May 26, 2020 to May 26, 2021, but it has now been picked up and rectified by the Council). This delay also means that the requirements of the Regulation on Post-Market Surveillance (including vigilance), market surveillance, Periodic Safety Update Reports (PSURs), and registration of economic operators and devices do not apply until May 26, 2021.
For example, the 15-day vigilance reporting period (as per MDR Article 87.3) will apply to all devices from May 26, 2021, regardless of the route to market (CE Mark under MDR or under MDD/AIMDD). Despite having this extra year available, manufacturers need to ensure that their complaint management processes are well able to cope with the requirements, especially of the shortened timeline. This means they must streamline the process of getting information and implicated products from the field, and speed up investigations and decision-making to avoid, wherever possible, submitting reports that later may turn out to be non-reportable.
Key Revised Dates based on MDR Regulation Amendment Proposal
|MDR Article||Subject||Original date as per MDR published EU OJ May 5, 2017||Proposed Amended MDR date|
|123.2||MDR to apply from:||May 26, 2020||May 26, 2021|
|120.1||NBs can issue MDD/AIMDD certificates until:||May 25, 2020||May 25, 2021|
|120.2||End of Grace Period Unchanged – all MDD/AIMDD certificates become void on:||May 27, 2024||May 27, 2024|
|120.3||Transitional provisions of MDR on PMS including vigilance and PSURs and registration of economic operators and products, delay to kick-in date for all devices:||May 26, 2020||May 26, 2021|
|120.4||End of “sell-off” period (unchanged):||May 26, 2025||May 26, 2025|
Based on information available April 14, 2020
No extension to “sell-off” period
The “sell-off” period during which MDD/AIMDD-compliant devices which, according to Article 120.4 are placed on the market prior to May 26, 2021, may continue to be made available on the market or put into service is not extended, and will end, as per current MDR text, on May 26, 2025. There is concern within the industry that this may result in a shortage of some products.
Under Article 34.1, the timeline for the notice to be published to confirm that Eudamed is fully functioning is being pushed back by one year to March 25, 2021 (i.e., two months prior to the new Date of Application). This new timeline is curious, given that in October 2019 the Commission announced informally that Eudamed would be introduced for the two Regulations (MDR and IVDR) simultaneously in May 2022. Is the proposed new date in the regulatory text an indication that it may yet be possible to introduce Eudamed prior to the (delayed) May 2022 date? Again, clarification is needed.
Amendment on derogations
A key new provision, not related to the delay in the DoA, relates to the provisions of Article 59 on derogations from conformity assessment procedures. The amendment is intended to facilitate EU-wide derogations under some circumstances. This is important now, in the light of the COVID-19 situation, and will allow certain devices to be made available in emergency situations, which may not have gone through the full conformity assessment procedures.
Other delayed provisions
Additional provisions mean that Common Specifications for Annex XVI products (those without a medical intended purpose) and for reprocessing of single-use devices are not required to be completed until May 26, 2021.
SmartSolve QMS for MDR
It is important to remember that the new MIR form (currently rev. 7.2) became a requirement, independent of EU MDR, effective Jan. 1, 2020, and is unaffected by the MDR delaying proposal. IQVIA SmartSolve® Complaint Management currently contains the latest MIR form out of the box, and the solution’s next release will include mapping to the IMDRF codes as well. The 15-day reporting timeline for most vigilance reports is also included. IQVIA’s Quality Compliance Services can support with consulting services around Complaint Management and vigilance reporting processes.
Whilst the Commission proposal concerns only the MDR, and the timelines on this are clearly pressing, there are calls from industry, led by MedTech Europe, for the date of application of the In Vitro Diagnostics Regulation (IVDR, 2017/746) to be delayed beyond May 25, 2022. This currently seems unlikely, but time will tell.
We will aim to keep you updated on the progress of the proposal. In the meantime, it is advisable to continue planning to ensure your preparedness for the MDR. When NBs and other stakeholders are able to get back to standard schedules, there is potential for an even bigger backlog to catch up on, so manufacturers need to be ready when NBs are ready.
Support going forward
As the fight against COVID-19 forges on, IQVIA is mobilizing its capabilities and resources to help governments, patients, healthcare providers, life sciences, and others understand what’s happening and how we can reduce the impact of this virus, together.
Above all, we are committed to helping everyone in healthcare to do what needs to be done to keep things moving forward in this new reality. With the delay in key EU MDR dates, IQVIA Quality Compliance stands ready to support its network of medical device manufacturers with process planning and execution consulting services.
1 Commission working on proposal to postpone MDR application date for one year
2 Commission proposal text COM(2020) 144 final
3 Council of the European Union, Doc 7180/20 of 7 April 2020: Mandate for negotiations with the European Parliament on the Commission’s proposal to amend MDR
4 MedTech Europe calls for a pause on IVDR and MDR implementation to facilitate the fight against COVID-19 and to safeguard Healthcare Systems
5 MDD: Medical Devices Directive 93/42/EEC; AIMDD: Active Implantable Medical Devices Directive 90/385/EEC