With the young green leaves growing after the cold winter, no month is more suited to leave your old ways behind and start something new than April. This month’s MedTech Gateway from Access-2-Healthcare is here to help you renew your vigour for all things related to medical technology.


From Saturday 1 April 2023, new fees are being introduced for a range of MHRA services, to ensure the agency covers its costs and achieves financial stability in the years ahead. This will enable the MHRA to deliver a responsive and efficient regulatory service that protects and improves patient and public health by facilitating access to high-quality, safe, effective and innovative medical products.

MHRA fees for 2023 - 2024 have increased from 2022 - 2023



Instruction PS 1/2023 on the process for obtaining a preliminary license

Directions for processing operating licenses for sanitary product installations, as well as their changes and revalidations (Update of the prior instruction PS1/2022, which was published on March 21 to reflect new requirements). Healthcare facilities and the industry for healthcare items will be affected by this instruction. The new royal decree on medical equipment for "in vitro" diagnosis will take the place of the existing Royal Decree 1662/2000, of September 29, and the instructions will be modified once more.



The instructions for submitting combination trials and for submitting previously authorized studies that are now being converted to combined trials have been modified by Swissmedic.

Announcements about medical device clinical trials and vitro diagnostic device performance studies


Regulation (EU) 2017/745 on medical devices (MDR):

1.  3EC International (Slovakia) – 2265

2.  BSI (Netherlands) – 2797

3.  BUREAU VERITAS (Italy) – 1370

4.  Berlin Cert Pruf (Germany) - 0633

5.  CE Certiso (Hungary) – 2409


7.  CERTIQUALITY S.r.l. – 0546

8.  DEKRA Certification (Germany) – 0124        

9.  DEKRA Certification (Netherlands) – 0344

10.  DNV MEDCERT GMBH (Germany) - 0482

11.  DNV Product Assurance AS (Norway) – 2460

12.  DQS Medizinprodukte (Germany) – 0297 

13.  ENTE Certificazione Macchine SRL (Italy) – 1282

14.  Eurofins Electric & Electronics Oy (Finland) – 0537

15.  Eurofins Product Testing Italy S.r.l. (Italy) – 0477

16.  GMED SAS (France) – 0459

17.  ICIM S.P.A (Italy) – 0425

18.  IMQ (Italy) – 0051

19.  Institut Pro Testovani A Certifikaci (Czech Republic - 1023

20.  Intertek Medical Notified Body AB (Sweden) – 2862

21.  Istituto Superiore Di Sanita’ (Italy) – 0373

22.  ITALCERT SRL (Italy) – 0426

23.  KIWA CERMET ITALIA S.P.A (Italy) – 0476

24.  Kiwa Dare B.V (Netherlands) – 1912

25.  MDC Medical Device Certification (Germany) – 0483

26.  NSAI (Ireland) – 0050

27.  Polskie Centrum Badan I (Poland) - 1424

28.  SGS Belgium NV (Belgium) – 1639

29.  SGS FIMKO OY (Finland) – 0598

30.  SLG Pruf and Zertifizierungs (Germany) - 0494

31.  Slovenian Institute of Quality and Metrology – SIQ (Slovenia) – 1304

32.  SZUTEST Konformitatsbewertungsstelle (Germany) – 2975[NH1] 

33.  TUV NORD Polska (Poland) – NB 2274

34.  TÜV NORD CERT GmbH (Germany) – 0044

35.  TÜV Rheinland Italia SRL (Italy) – 1936

36.  TÜV Rheinland LGA (Germany) – 0197

37.  TÜV SÜD (Germany) – 0123

38.  UDEM Adriatic d.o.o. (Croatia) – 2696

Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR):

1.  3EC International (Slovakia) – 2265 

2.  BSI (Netherlands) – 2797

3.  DEKRA Certification (Germany) – 0124 

4.  DEKRA Certification (Netherlands) – 0344 

5.  GMED SAS (France) – 0459 

6.  MDC Medical Device Certification (Germany) – 0483

7.  National Standards Authority of Ireland (Ireland) - 0050[NH1] 

8.  QMD Services (Austria) – 2962

9.  TÜV Rheinland LGA Products (Germany) – 0197

10.  TÜV SÜD Product Service (Germany) – 0123 



1.  BSI Assurance (UK) – 0086

2.  DQS Polska (Poland) – 2282

3.  ECM (Germany) – 0481

4.  GMED SAS (France) – 0459

5.  Presafe (Denmark) – 0543

6.  SGS United Kingdom Limited (UK) – 0120


Research boost for chronic disease prevention in Asia Pacific

$5.7 million in research grants has been awarded to four projects aiming to foster research partnerships between institutions in Australia and the Asia-Pacific region and improve health outcomes for chronic conditions. The collaborative projects, funded through the National Health and Medical Research Council through the Global Alliance for Chronic Diseases, will enable knowledge-sharing and capacity building for better health and wellbeing outcomes.



Singhealth and a*star establish s$8 million partnership to co-develop healthcare innovations and translate research from bench to bedside

SingHealth and the Agency for Science, Technology and Research (A*STAR) announced on April 11, 2023 a Healthcare Translation Partnership (HTP) to accelerate the translation, deployment and commercialisation of healthcare research and innovation projects for better patient care. The partnership, which will provide S$8 million in funding support for projects, focuses on three healthcare innovation areas - (i) Medical Technology, (ii) Data Science, Artificial Intelligence (AI) and Digital Health, and (iii) Health Services Innovation.



Neuromod Closes €30 Million Financing to Expand Availability of Lenire®

Neuromod Devices Ltd, an Irish medical device company specialising in neuromodulation, has successfully closed a €30 million financing to further commercialise its tinnitus treatment device, Lenire. Lenire has shown in large scale clinical trials to reduce tinnitus severity. The device has recently been granted De Novo approval from the US Food and Drug Administration (FDA) and is available throughout Europe.


A strategic cooperation deal between Oxford Nanopore and bioMérieux will be signed in order to create cutting-edge infectious disease diagnostics.

Today, it was revealed that Oxford Nanopore Technologies and bioMérieux SA, a market leader in in vitro diagnostics, have partnered to enhance health outcomes all around the world by looking at prospects to introduce nanopore sequencing to the infectious disease diagnostics industry.

Process flow

Distributors not reaching their full potential

- How to maximise them -

A very specific medical device, for a very specific market segment

A distributor of many years, which understands the device and market.

All good, sounds good. Or is it?

What if the distributor did not tap the full potential of the market? True that it would be challenging to grab all or even the majority of market share, but perhaps the distributor could do more?

What if the distributor was not initially from this device segment, and learnt it along the way from the manufacturer? Would it benefit more by having a distributor more to this specific market segment?

If the country is too large, would more than one distributor be required? If yes, would one of the distributors become the master distributor?

There are some suggested solutions:

Have a country / area sales manager under the manufacturer’s payroll. Having a person on the ground to be in the distributor’s face will ensure that there is some promotional efforts for your product. However, this comes with a cost, sometimes inconsistent talent pool, and the most common issue of all – staff turnover. Sometimes there is this wish to apoptin more distributors just to ‘make full use of’ this resource.

License holding, so that the license is with an independent party, and the distributors are managed from there. Again, it costs money, and the legislation may not entirely be what the manufacturer wants. Finally, the chances of lack of cooperation from the distributors are high (because the license holder is taking their leverage away).

Whichever the way, there is one fundamental to remember. Nothing is free. Invest before harvesting returns. It is important to see the upsides before investing – fair and reasonable. Just to ensure that the reasons are not just to avoid risky business situations, but to develop a great upside for future sales.

Leave your coat behind as the weather gets warmer and enjoy these events to meet new people!

Art and Science of Dentistry 2023

May 18-20, 2023

Anaheim, USA


May 10-12, 2023

Seoul, Korea

ASGH 2023 (Asia Summit on Global Health)

May 17-18, 2023

Hong Kong (in person/online)

CMED (China International Medical Equipment Fair)

May 14-17, 2023

Shanghai, China

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