wɔ 28 th . April 2022, Joytech nyaa EU MDR a wɔde mae mfiase no maa yɛn mogya mmoroso monitors a ɛnyɛ nea ɛhyɛ yɛn so no,wubetumi ahu nsɛm no mu nsɛm ha.
Wɔ afe 2023 mu no, Joytech contact thermometers, non contact thermometers ne mogya mmoroso monitors foforo nyinaa yɛ nea EU MDR apene so.
Dɛn ne CE (MDR)?
Sɛ ɛba CE adansedi nkrataa so a, obiara nim no yiye. Ɛkame ayɛ sɛ nnwuma biara wɔ CE adansedi krataa a ɛne no hyia. MDR yɛ Europa aduruyɛ mfiri ho mmara a wɔatwa no tiawa, a ɛyɛ CE (MDD) a wɔayɛ no foforo na ɛde ahwehwɛde a ɛkorɔn to aduruyɛ mfiri ahobammɔ ne ne dwumadi so. Yɛsan nso frɛ no CE (MDR).
Nsonsonoe bɛn na ɛwɔ CE (mDD) ntam ne CE (MDR) mu?
MDR yɛ mmara na MDD yɛ akwankyerɛ. Esiane sɛ ɛyɛ nkɔso nti, efi akwankyerɛ ahorow so kosi mmara so no, aman a wɔka ho no bedi adansedi nhyehyɛe no ne nea efi mu ba no so denneennen.
a ɛda adi titiriw wɔ afã horow a edidi so yi mu:
1) Ɔhyɛɛ nea ɔyɛe no asɛyɛde ahorow mu den.
a) anyɛ yiye koraa no, ɛsɛ sɛ nea ɔyɛ no nya ɔpanyin biako a ɔhwɛ ma wodi mmara so a ɔwɔ nimdeɛ wɔ nnuruyɛ mfiri ho (ahwehwɛde biara nni hɔ a ɛda adi pefee wɔ MDD Akwankyerɛ no mu);
b) Nea 3b3y3 no b3hy3 na wakɔ so asiesie mfiridwuma ho nkrataa na wahw3 s3 3w) mu ber3 a 3man no mu Aban a 3fata abisa no.
c) Ɛsɛ sɛ wɔn a wɔyɛ no yɛ wɔn adeɛ wɔ nhwehwɛmu a nnwumakuo a wɔabɔ wɔn amanneɛ a wɔammɔ ho amanneɛ no yɛ ho biribi berɛ biara de hwɛ sɛ wɔayɛ mfiridwuma ho nkrataa foforɔ na wɔahwɛ nhyehyɛeɛ no so; (Adesua a ɛto so II) .
d) Wɔ nnwuma a asiane kɛse wom a aguadi nnwumakuw yɛ no fam no, ɛbɛyɛ den kɛse sɛ wɔbɛhwehwɛ CE.
2) Mmara ho nhyehyɛe a ɛkɔ soro ne adansedi nhwehwɛmu a emu yɛ den.
a) mmara a ɛkɔ soro: efi 18 wɔ MDD mu kosi 22 wɔ MDR mu;
b) Wɔma nneɛma titire a wɔhwehwɛ no so: ɛfiri nneɛma 13 a ɛwɔ MDD mu kɔ nneɛma 23 mu wɔ MDR mu;
c) CE mfiridwuma ho nkrataa nhyehyeɛ asesa na wɔakyekyɛ mu ayɛ no: afiri ho mfiridwuma ho nkrataa ne nkrataa a wɔde di gua akyi (MDD hwehwɛ sɛ wɔde afiri ho mfiridwuma ho nkrataa nko ara);
d) Ayaresabea Nhwehwɛmu Amanneɛbɔ. MDR hwehwɛ sɛ nnwumakuw de ayaresabea nhwehwɛmu amanneɛbɔ a ɛto so anan no ma, a ɛyɛ katee sen nea ɛto so abiɛsa no;
3) Expanded scope of application .
a) MDD de nnuru di dwuma nko ara, bere a MDR de mfiri bi a ɛnyɛ aduruyɛ ka ho kɔ baabi a wɔde di dwuma, te sɛ nhabannuru a wɔde hwɛ wɔn ho, nneɛma a wɔde yɛ ahoɔfɛ, ne nea ɛkeka ho;
b) Wɔ MDD no mu no, wɔkyekyɛ mfiri a wɔde di dwuma bio mu sɛ nnuruyɛ mfiri kuw na enhia sɛ kuw bi a wɔabɔ wɔn amanneɛ de wɔn ho hyɛ mu, bere a MDR hwehwɛ sɛ kuw a wɔabɔ wɔn amanneɛ no yɛ oprehyɛn a wɔde di dwuma bio ho nhwehwɛmu a ɛne no hyia;
4) MDR hwehwɛ sɛ wɔma ɛda adi kɛse na wotumi hwehwɛ mu yiye .
a) de afiri a ɛma wohu ade soronko UDI no baa mu sɛnea ɛbɛyɛ a nneɛma a wɔde di dwuma no tumi tra ase no yɛ kɛse;
b) Wɔbɛboaboa Adwumakuw no nsɛm a ɛfa ho ano akɔ Europa Aduruyɛ Mfiri Ho Nsɛm a Wɔakora so (EUDAMED) mu;
c) Fa nhyehyɛe a wɔde hwɛ gua so akyi (PMS) nhyehyɛe bi si hɔ;
d) Body a wɔabɔ no amanneɛ no bɛyɛ nhwehwɛmu a wɔammɔ ho amanneɛ.
Dɛn ne MDR CE ho nhwehwɛmu a wɔyɛ wɔ ayaresabea?
Ayaresa mu adeyɛ a yɛreka ho asɛm no, wɔ ɔkwan a ɛkɔ akyiri so no, wɔkyekyɛ mu abien:
a) Wɔde nnuruyɛ mu sɔhwɛ ahorow di dwuma wɔ nnipa so de nya nsɛm de kyerɛ sɛ ade no yɛ nea ahobammɔ wom.
b) Ayaresa ho amanneɛbɔ titiriw di adanse sɛ ahobammɔ ne mfaso a ɛwɔ aduru no so denam aduru no a wɔde toto ho (a efi afã abiɛsa so: ayaresabea ho nsɛm, mfiridwuma mu nsɛm, ne abɔde a nkwa wom adwumayɛ), nsɛm a wɔde hwehwɛ nsɛm mu, ne nhoma mu nhwehwɛmu.
c) Ayaresabea Nhwehwɛmu Amanneɛbɔ no yɛ CE mfiridwuma ho krataa no fã na ɛsan nso yɛ ade titiriw (Ayaresa Nhwehwɛmu Amanneɛbɔ no yɛ amanneɛbɔ a ɛho hia wɔ CE mfiridwuma ho krataa no mu bere a wɔrebisa CE adansedi krataa no).
D) Mprempren, wɔde Clinical Evaluation Report no fã a ɛtɔ so nnan no di dwuma, a ɛyɛ ayaresabea nhwehwɛmu amanneɛbɔ a wɔaboaboa ano sɛdeɛ Clinical Evaluation Guideline Meddev 2.7.1 kyerɛ no.
MDR adansedi krataa a ɛretwam no kyerɛ sɛ . Joytech mogya mmoroso monitor ne . Digitals thermometer adu gyinapɛn a emu yɛ den ho wɔ nhyehyɛe, nneɛma a wɔyɛ ne nea ɛyɛ papa sohwɛ mu, na ebetumi ama wɔn a wɔde di dwuma wɔ wiase nyinaa anya aduruyɛ mu mfiri a ahobammɔ wom na wotumi de ho to so.
JoyTech mogya mmoroso monitor ne digital thermometer anya ayeyi a ɛyɛ biako fi wɔn a wɔde di dwuma no hɔ wɔ wɔn susudua a ɛyɛ pɛpɛɛpɛ, nhyehyɛe a ɛyɛ mmerɛw sɛ wɔde bedi dwuma ne adwumayɛ a ɛkyɛn so ho. Seesei, wɔatwam MDR adansedie, a akyinnyeɛ biara nni ho sɛ ɛbɛma wɔn a wɔde di dwuma no ahotosoɔ ne wɔn akomatɔyam akɔ soro bio wɔ yɛn nneɛma mu.
JoyTech Healthcare bɛkɔ so ayɛ krado sɛ wɔde bɛma . Aduruyɛ mfiri a ɛyɛ papa na ɛboa ma wɔde di dwuma wɔ wiase nyinaa akwahosan. Yɛgye di sɛ ɛnam yɛn mmɔdenbɔ so no, yɛn nneɛma a ɛyɛ papa no bɛboa wo asetena pa wɔ wiase nyinaa gua so.
Sɛ wowɔ nsɛmmisa anaa ahiade bi fa yɛn mogya mmoroso monitor ne thermometer nneɛma ho a, yɛsrɛ wo, ntwentwɛn wo nan ase sɛ wobɛka ho asɛm.
