MedTech Report 2020: EU MDR and IVDR Compliance

This research report from MedTech Summit reveals unique insights into EU MDR and IVDR compliance based on 256 survey responses from industry insiders.

MedTech Report 2020: EU MDR & IVDR Compliance

March 2020

Summary and Respondent Demographics

MDR & IVDR Compliance

Introducing the MedTech 2020 Report...

As we enter 2020 with fewer guidance documents and certified Notified Bodies than expected, the preparation for the EU MDR is more crucial than ever. With only a few more months on the clock, is industry ready? Can companies be truly prepared with so much still to be decided with the EU MDR? Do Notified Bodies have the capacity and time to handle all MDD and EU MDR certificates heading their way? Meanwhile, we are half way through the IVDR implementation period. How can IVD companies learn from EU MDR implementation procedures?

MedTech Summit recently conducted (Feb 2020) one of the biggest surveys of its kind, asking these questions to medical device and IVD professionals around the world. This final report based on 265 responses reveals unique insights into the readiness of industry today as we head towards the key 2020 and 2022 deadlines, as well as the biggest challenges and how industry insiders are tackling them.

Click on any of the graphics throughout this report to interact and explore the data.

Most respondents work at medical device or software organisations

Philip Greenfield, Editor-In-Chief at Medtech Insight, introduces the report and offers analysis throughout.

"Over the last three decades, the US FDA has had a reputation for being much stricter than the EU for medtech regulation, and so the EU has been a more attractive and rapid product launch market. Now the tables have reversed.

The EU Medical Device Regulation (MDR), which comes fully into force in May, and the In Vitro Diagnostic Regulation (IVDR), which follows two years later, significantly raise the regulatory bar compared with the current EU directives."

Job Function: Half of all respondents work in Regulatory Affairs

86% of respondents work with medical device products

75% of respondents are at the level of 'manager' or above

66% of respondents represent organisations of over 100 employees

92% of respondents are based in Europe or North America

EU MDR Implementation

How prepared is industry for the EU MDR?

"Companies feeling the pressure to be EU MDR-compliant want more guidance from the European Commission than they are getting, as well as more time and resources, including capacity at Notified Bodies. Around a third of respondents want to see more Notified Bodies in place, reflecting the fact that to date, the number of Notified Bodies designated to work under the EU MDR is far below what industry had expected.

Specific comments from respondents also highlight concerns about the Notified Bodies’ frequent struggles to find enough resources to certify all companies. They fear that Notified Bodies are unprepared, with an insufficient number of auditors and a lack of understanding about how long it will take to gain CE marking under the EU MDR."

- Philip Greenfield, Medtech Insight

Just 17% of respondents think that their company is 'fully prepared' for EU MDR implementation

*Excluding 'Not Applicable' (14)

Of those not fully prepared for implementation, a lack of guidance dominated the reasons why (selected responses):

"A lot of procedures still need to be updated and some require guidance docs that are not yet available."
"There is a sense of confusion, compounded by Brexit."
"The lack of guidance and Notified Body experience."
"My company initially underestimated the effort to become MDR compliant AND there is a clear lack of guidance from the Competent Authorities."
"Discussions about some interpretations, guidances which are not written or published, timelines which are not realistic anymore."
"Incomplete standards."
"Insufficient time to prepare due to Notified Body withdrawal causing other more immediate issues."
"Lacking people, IT resources and legal consultation."
"There are many unknowns; we have actions in place and believe we have covered off the elements required, but with interpretation issues in the mix, who knows?!"
"Still finalising some aspects of PMCF and technical file templates."
"Notified Body uncertainty and hence ability to plan."
"Our Notified Body is not yet designated to the EU MDR."
"UK govt (MHRA) guidance delayed. Lots of minor issues, but in house manufacture a key one."

Which of the following do you need more of to be fully prepared for EU MDR implementation?

Of those who answered 'Other', their responses were varied:

"Availability of regulator colleagues for joint work on guidances."
"Awareness. This is because nearly half of US companies are closing their doors for EU market."
"EUDAMED requirements published for all sections of the database."
"Guidance from NBs not only the EC on how some requirements practically need to be fulfilled eg without EUDAMED how will the documentation be made available."
"MDR regulations for the UK."
"More transition allowances (e.g. being able to manage changes to products on existing certificates prior to transition)."
"Our NB is struggling to find sufficient resource to certify all companies. Many EC processes not in place e.g. EUDRACT PSUR template."
"Our Notified Body is designated but not prepared. They do not have enough trained auditors / reviewers they are unable to schedule audits and they seem unsure as to how long it will take them to complete the certification process and issue the CE Certificate."
"Understanding from the Legal Manufacturer of the actual impact of the MDR."

MDD product certificates

"While a vast majority of companies feel they are prepared for the new regulatory environment to some degree, three quarters are extending their certificates under the existing Medical Device Directive (MDD), potentially up until May 2024, and most are planning to use the entire MDD certificate time to get MDR-ready. That said, companies are concerned about losing important products from the market due to the application of the EU MDR."

What proportion of your products have you
extended your MDD certificate for?

*Excluding 'Not Applicable' (63)

67% of respondents are planning on using their
entire MDD certificate time to get EU MDR ready

*Excluding 'Not Applicable' (70)

34% of respondents are 'somewhat' or 'very concerned' about losing important products from the market post EU MDR application

*Excluding 'Not Applicable' (49)

Most respondents think that it is the job of the European Commission to monitor any lost products

If you could ask a Competent Authority one question on the EU MDR anonymously, what would it be?

"Until EUDAMED comes in force, where should a Trend Report be sent to?"

"Are you going to allow additional time to medical device companies within your jurisdiction that do NOT make the MDR deadline?"

"Could you please clearly define "sufficient clinical data" as this is a crucial point for interpretation."

"Would there be enough Notified Bodies designated for the MDR?"

"Can you work to get European wide derogation of CE marks that have been orphaned?"

"How will EUDAMED interface with national databases?"

"Given that language is imperative to the safe and correct use of medical devices, will there be further guidance from the EU on local language requirements beyond the simple statement that language is regulated by NCAs?"

"Do you envisage many inspections?"

"How strictly will you apply the MDR rules after 26 May 2020?"

"What is the most critical milestone most early stage companies should focus on?"

"How confident are they that implementing MDR will guarantee better safety records for the products?"

If you could ask your Notified Body one question on the EU MDR anonymously, what would it be?

"Should we expect the same backlog we face for MDD renewal with MDR certification?"

"Are you planning to get designated for the MDR?"

"Do you plan to create an expert team within your organization for drug-device combination?"

"How much has changed in the review and audit process from the MDD to the MDR?"

"To what level of detail are you going to go when examining our Technical Files?"

"Can you accept the approval of another Notified Body without having to review files, and review them when they are up for renewal?"

"What are the most important new requirements that will be inspected for?"

"Could we get clear guidance on tech file preparation?"

"What is in your opinion the approximate average approval time for a MD class III under MDR?"

"How will you provide adequate service to your customers, such as timely review of Technical File submissions and change notifications?"

"Are you working to collaborate with the Competent Authorities on interpretation where there is no guidance available?"

"When are you planning to take new clients?"

IVDR Readiness

Preparing for IVDR implemantation

EU IVDR Implementation Readiness

"Perhaps unsurprisingly, there appears to be less concern about the IVDR, which comes into force in May 2022, although almost two thirds of those surveyed have not worked with a notified body for an IVD product before.

The biggest unknown seems to be around clinical data requirements for IVDs. As the IVDR edges closer, companies will be hoping some important lessons from the implementation of the EU MDR can be learned."

Philip Greenfield, Medtech Insight

Respondents are split when asked how prepared their company is to hit the EU IVDR deadline

61% of respondents say that increased guidance from the European Commission is the main thing needed to be fully prepared for IVDR implementation

Working with Notified Bodies

65% of respondents have never worked with a Notified Body for an IVD product before

What impact has Notified Body allocation had on your company in regards to IVD products so far?

*Excluding 'Not Applicable' (36)