MedTech Europe posi­tion papers — dig­i­tal labels & re-certification

Indus­try asso­ci­a­tion MedTech Europe has pub­lished two joint posi­tion papers: a joint indus­try Dig­i­tal Label for Autho­rised Rep­re­sen­ta­tive and Importer advo­cat­ing e-labelling for autho­rized rep­re­sen­ta­tive (AR)/ importer details, and Re-cer­ti­fi­ca­tion under the MDR and IVDR analysing the prac­ti­cal and pol­i­cy issues around five-year re-cer­ti­fi­ca­tion. Both are inter­est­ing reads for reg­u­la­to­ry affairs professionals. 

Dig­i­tal-label posi­tion — back­ground & pur­pose
Indus­try argues that manda­to­ry on-pack require­ments have grown, cre­at­ing over­crowd­ed labels and sup­ply-chain fric­tion. The paper calls for allow­ing AR and importer details to be pro­vid­ed via a machine-read­able link to curat­ed online con­tent (a “dig­i­tal label”), align­ing with lat­est eIFU pro­vi­sions, EUDAMED data avail­abil­i­ty and oth­er EU dig­i­tal ini­tia­tives, while reduc­ing waste and rela­belling bur­dens. It rec­om­mends pri­ori­tis­ing AR/ importer data in the revi­sion of the med­ical devices reg­u­la­tions (MDR/ IVDR) as a first step toward broad­er e-labelling. Prac­ti­cal ben­e­fits high­light­ed include faster mar­ket access after oper­a­tor changes, improved usabil­i­ty, and envi­ron­men­tal gains. 

Re-cer­ti­fi­ca­tion FAQs — back­ground & pur­pose
The FAQ explains that cer­tifi­cates under the MDR and IVDR are valid five years and that re-cer­ti­fi­ca­tion requires dossier resub­mis­sion — even where prod­ucts are unchanged. MedTech Europe warns this dupli­cates exist­ing con­tin­u­ous over­sight (sur­veil­lance audits, PMS/vigilance, change noti­fi­ca­tions) and risks a “cer­ti­fi­ca­tion bot­tle­neck” (peaks 2026–2028), sup­ply dis­rup­tion, dis­pro­por­tion­ate costs, and inequitable effects on ear­ly reg­u­la­tion adopters. The paper sets out pol­i­cy alter­na­tives: con­tin­u­ous risk-based sur­veil­lance, tar­get­ed reviews trig­gered by sig­nals, or life­time cer­ti­fi­ca­tion with clear exit/trigger mech­a­nisms. It calls for har­monised noti­fied body pro­ce­dures and leg­isla­tive or sec­ondary-law solu­tions to avoid capac­i­ty cliffs and pre­serve patient access.

Source: MedTech Europe

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

• Updates for Switzer­land – eIFU and device registration
• Elec­tron­ic Instruc­tions for Use (eIFU) for Pro­fes­sion­al Use Med­ical Devices
• Med­ical tech­nol­o­gy indus­try calls for urgent EU action