Med­ical tech­nol­o­gy indus­try calls for urgent EU action

The EU med­ical tech­nol­o­gy indus­try faces crit­i­cal chal­lenges that demand imme­di­ate atten­tion. This was the mes­sage of an open let­ter from MedTech Europe and 39 nation­al asso­ci­a­tions to the Euro­pean Com­mis­sion, which was already pub­lished in Octo­ber 2024. The let­ter voic­es sim­i­lar con­cerns expressed by the Par­lia­ment and Coun­cil, which were men­tioned in pre­vi­ous newslet­ter issues. 

MedTech Europe warns that wait­ing until 2025 for the eval­u­a­tion of the Med­ical Devices Reg­u­la­tion (MDR) and In Vit­ro Diag­nos­tic Med­ical Devices Reg­u­la­tion (IVDR) is too late and call for swift mea­sures to address bar­ri­ers impact­ing the avail­abil­i­ty and com­pet­i­tive­ness of med­ical devices.

Key Bridg­ing Mea­sures Proposed

The asso­ci­a­tions empha­size the need for inter­im solu­tions to safe­guard the med­ical device sup­ply and ensure indus­try via­bil­i­ty ahead of long-term leg­isla­tive reforms. They propose:

• Stream­lined Cer­ti­fi­ca­tion: Reduce the time, cost, and unpre­dictabil­i­ty of cer­ti­fi­ca­tion to pre­vent fur­ther mar­ket exits and boost innovation.
• Faster Eval­u­a­tions: Sim­pli­fy the review process to speed up patient access to new technologies.
• Pri­or­i­ty for Inno­va­tion: Intro­duce fast-track cer­ti­fi­ca­tion for ground­break­ing devices to ensure Europe remains competitive.
• Life­cy­cle Cer­ti­fi­ca­tion: Adopt a life­cy­cle approach to cer­ti­fi­ca­tion to reduce com­pli­ance bar­ri­ers and avoid delays.

Addi­tion­al Areas of Focus

1. Tar­get­ed Reforms: Leg­isla­tive updates post-2025 must align with the orig­i­nal goals of MDR and IVDR.
2. Imple­men­ta­tion Improve­ments: Sug­ges­tions include low­er­ing doc­u­men­ta­tion sam­pling require­ments, enabling increased use of elec­tron­ic instruc­tions for use, and pur­su­ing glob­al har­mo­niza­tion through ini­tia­tives like the Med­ical Devices Sin­gle Audit Pro­gramme (MDSAP).

The indus­try also advo­cates remov­ing the five-year cer­ti­fi­ca­tion valid­i­ty require­ment under MDR and IVDR. With noti­fied bod­ies con­duct­ing annu­al assess­ments, this change could reduce bureau­cra­cy, cut costs, and pre­vent recer­ti­fi­ca­tion bottlenecks.

The let­ter under­scores the urgency of these actions to ensure that Europe remains a leader in med­ical inno­va­tion while main­tain­ing access to safe and effec­tive devices for patients.

MedTech Insight. Aman­da Maxwell. Octo­ber 17, 2024

Sum­ma­ry: The EU med­ical tech­nol­o­gy indus­try is fac­ing seri­ous chal­lenges that require urgent action, accord­ing to an open let­ter from MedTech Europe and 39 nation­al asso­ci­a­tions to the Euro­pean Commission.

Source: Medtech Insight (an Infor­ma product)

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

Coun­cil of the Euro­pean Union pro­pos­es key ele­ments for MDR/ IVDR reform