Data Analysis

The vast majority of respondents (93%) work with medical devices, with a third working with diagnostic devices and a quarter combination products.

When looking at the EU MDR classification(s) the products fall under, the results are a little more spread. Over half of respondents have products classified under IIa, IIb and/or III.

93% of respondents are working with medical devices

"What product type(s)
do you work with?"

Products are fairly evenly spread across EU MDR classification(s)

"Which EU MDR classification(s) do your products fall under?"

Three quarters of products are still registered under an MDD extended certificate

"What percentage of your products and legacy devices are registered under EU MDR or MDD?"

The vast majority of products (75%) are still registered under an MDD extended certificate, with just 25% under the EU MDR.

This is even more stark for legacy devices, with just 20% registered under the EU MDR.

*Excluding 'Don't know' (27)

43% of organizations have withdrawn products from the market as
a result of the transition to the EU MDR

"Has your organization withdrawn any products from the market as a result of the transition to the EU MDR?"

With issues surrounding EU MDR implementation, there was concern within the industry that products would be withdrawn from the market as a result of the transition to the EU MDR. The data is generally positive around this, with over half of organizations (57%) not having withdrawn any products, and none having withdrawn 'most' or 'all' of their products.

However, conversely, 43% of organizations have withdrawn 'some' products from the market.

*Excluding 'Not applicable' (21)

What are the biggest challenges you have found registering legacy products under the EU MDR? (Selected responses)

"Eudamed DI codes, for legacy devices registered in the Eudamed database."
"Clinical data collection"
"Clinical documents - CEP, CER, PMCF Plan, PMCF Report, SSCP"
"Clinical evidence for few indications"
"Clinical study recruitment rates with COVID"
"Confusion over the differences between the EU and UK requirements"
"Data collection and governance."
"Notify Body capacity"
"Duplication of technical files, MDD and MDR, also retrospective validation and verification."
"Enough data for the clinical evaluation"
"Establishing Quantitative performance and safety indicators and setting acceptance limit to the same based on state of the art. Establishing quantitative benefit risk ratio."
"EUDAMED, clinical data and evaluating what is enough"
"Generating Clinical Evidence"
"Generating the right technical documentation"
"Unclear national registration procedures as the EUDAMED is not yet working"

"There is a great amount of guidance and information being published in a short amount of time - it is difficult to keep up along with daily activities"
"Insufficient clinical data and risk management files"
"Internal resource"
"Lack of notified bodies; lack of (harmonized) standards and guidance; volume of work on top of day job"
"Lots of documentation efforts (esp. on the clinical side) with no value add as products have been in the market for years"
"No mutual recognition arrangements with other jurisdictions.
none or limited practical advice from regulators, harmonized practical guidelines are missing, limited knowledge about MDR at NCA responsible for DDC."
"Notified body timelines for review of MDR submissions."
"Re-classification"
"Re-Testing old devices"
"Resourcing & understanding enforcement for legacy products."
"The extended PMS requirements, especially clinical evaluation"
"Uncertainty on the interpretation of MDR, still huge differences in the way NB's work, capacity constraints at NB's, complexity of the registration process under MDR, COST!"

Employees from larger organizations feel they have fared better with EU MDR implementation than those working for smaller companies

"How do you feel your organization has fared with EU MDR implementation compared to others?"

In general, respondents felt their organizations had fared better with EU MDR implementation compared to others - with 44% believing they were 'above average' (33%) or 'best in class' (11%).

Interestingly, this number jumps to 57% for respondents from large companies (over 500 employees), versus just 31% for respondents from small companies (<50 employees).

This perhaps shows the burden of the new regulations on smaller companies who may not have the necessary resources to deal with it.

Just 8% of respondents feel their company's EU MDR processes are currently working at maximum efficiency, whilst 18% believe they are working at below average efficiency (1 or 2 out of 5).

These numbers vary depending on the EU MDR classification(s) their products fall under, with respondents working with class IIb and III products generally feeling happier - indeed 38% who work on class III products rated their efficiency as 4 or 5 out of 5.

18% of respondents feel their company's EU
MDR processes are currently inefficient

"How efficient do you feel your organization’s current EU MDR processes are?"

What are the main challenges you are facing with EU MDR implementation within your organization? (Selected responses)

"Resources"
"Agreements on what testing needs to be repeated and what justifications can be used, as well as how to collect PMCF Data."
"Buy-in from other teams"
"Capacities and limitations for new products and innovation. We invested a lot in old products to maintain them."
"Coordinated cooperation between departments to fulfill high data quality requirements"
"Cross-functional alignment & awareness of the significantly increased impact on resources."
"Finding experts for a reasonable salary"
"Getting it all done. Interpreting the regulations, e.g. understanding how much data is needed."
"Getting understanding and buy in from Senior Management as to the serious implications of non-compliance and thus the opportunity to reach clients as a specialty offering."
"Lack of understanding, too many products and different requirements."
"No specialists in the company for clinical affairs, arranging PMCF studies, and clinical studies."

What are the main challenges you are facing with EU MDR implementation outside of your organization? (Selected responses)

"Lack of prompt support from NBs"
"Change in customer priorities."
"Client understanding of issues like impact of Usability Studies, PMCF and implications for QMS Remediation as part of the MDR compliance. Complexity of PMSR and sources requirements for SOTA."
"COVID, clinial study recruitment rate slow, lack of NB designated to discuss alternative PMCF strategies for point of submission."
"End customers (integrators) outside Europe not fully understanding the restriction around not being able to put legacy MDD class I devices on the market after May 2021."
"EUDMED and suppliers far from ready"
"Notified Body availability"
"Lack of the Mutual Recognition Agreements that existed under the MDD. Clarity on the UK."
"Notified body timelines for review of MDR submissions."
"Overburdened Notified body, very slow process."
"The manufacturers, EU REPs, distributors and importers do not have any experience with MDR and they have little knowledge of the area."

Less than a quarter feel their organization fully understands
the requirements for ‘sufficient clinical evidence’

"To what extent do you feel your organization understands the
requirements for ‘sufficient clinical evidence’?"

Understanding of 'sufficient clinical evidence' is generally pretty high, with just 5% revealing their organization has no or little understanding of the requirements.

However, on the other hand, less than a quarter feel their organization 'fully understands' the requirements, so there is clearly still work to be done.

Ensuring Clinical Evaluation Reports (CERs) are valid is a challenge many organization's are currently facing, with a number of hurdles that need to be overcome to get there.

More staff is the top desire for respondents (51%), with an increase in budget (39%) and external consulting (36%) not too far behind. Interestingly, just 17% feel they need new or updated technologies.

Staffing is the resource companies are most
short of to ensure their CERs are valid

"Which of the following does your organization still need (more of) to ensure your CERs are valid?"

The UK Conformity Assessment (UKCA) mark will be required for certain products being placed on the market in Great Britain - with it fully replacing CE marking from the start of 2023. There appears to be some confusion around the marking still, with 48% of respondents not sure of the impact, or indeed if it will have an impact on their organization.

Of those who are clearer, 35% think it will have a negative impact, compared to just 18% who believe it will be a positive change.

Most respondents are unsure the impact or if there will
be an impact of the UKCA mark on their organization

"What impact do you expect the UKCA mark will have on your organization?"