The sub­ject of whether there should be an EU cen­tral med­ical device agency to man­age the reg­u­la­tion of med­ical devices has arisen again as a result of what many deem to be a fun­da­men­tal fail­ure of the imple­men­ta­tion of Reg­u­la­tions (EU) 2017/745 and 2017/746 on med­ical devices (MDR) and in vit­ro diag­nos­tic med­ical devices (IVDR). 

A white paper was issued by the Ger­man indus­try asso­ci­a­tions BVMed (med­ical devices) and VDGH (IVD med­ical devices). BVMed and VDGH are demand­ing less com­pli­cat­ed, more trans­par­ent and more eco­nom­i­cal solu­tions now, in advance of the planned eval­u­a­tion of the MDR in 2027. 

Among oth­ers, they urge:

  1. Use of post-mar­ket sur­veil­lance to exclude recertification.
  2. Addi­tion­al reg­u­la­tions, for exam­ple fast-track pro­ce­dures for inno­va­tions, orphan devices or niche products.
  3. Incor­po­ra­tion of the EU into the world-wide Med­ical Device Sin­gle Audit Pro­gramme (MDSAP) plus mutu­al recog­ni­tion agree­ments between the EU with Switzer­land and Great Britain.
  4. Con­sis­tent har­mon­i­sa­tion and cen­tral­i­sa­tion of the EU admin­is­tra­tive struc­ture, includ­ing for­ma­tion of an SME office at EU level.
  5. Improved effec­tive­ness by apply­ing the Euro­pean prin­ci­ples of good admin­is­tra­tive prac­tice, par­tic­u­lar­ly pre­dictabil­i­ty of dead­lines and costs, access to the sys­tem and trans­paren­cy of cer­ti­fi­ca­tion processes.

Experts have a con­tro­ver­sial per­spec­tive on the white paper. Some see many ben­e­fits of imple­ment­ing the paper’s pro­pos­als, but oth­er experts dis­agree. In actu­al fact, amend­ing the super­vi­so­ry struc­ture alone could take quite a few years and pos­si­bly until 2030-2040. 

Source: Medtech Insight (an Infor­ma product)

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website