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?"