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How to choose the right partner when marketing your Medical Devices

It may be difficult for a medical device company to choose the right partner and achieve its marketing goals, especially if part of the information is missing. That is why this choice is crucial to ensure that all regulatory requirements are met, research and development activities proceed smoothly and the time-to-market is as short as [...]

2022-09-05T11:12:30+02:00September 5th, 2022|BLOG|

EUROPE: PRRC, the Responsible Person in the MDR (EU) 2017/745

The Person Responsible for Regulatory Compliance (PRRC) is one of the most critical elements of MDR (EU) 2017/745 as the responsibilities of the PRRC impact on product documentation, system documentation and, more generally, on the entire organization of the Manufacturer or Authorized Representative. Necessary skills and minimum requirements: how to identify the PRRC Article 15 [...]

2022-08-01T11:13:12+02:00June 29th, 2022|BLOG|

THEMA becomes Enterprise member of the international Organization RAPS – Regulatory Affairs Professionals Society

It is with great pride and satisfaction that we announce that THEMA is joining to the international Organization RAPS - Regulatory Affairs Professionals Society (www.raps.org). This is further proof of THEMA constant commitment in the project of growth and professionalization of its internal human resources, and in improving the services offered to its Customers. THEMA [...]

2022-08-01T13:04:46+02:00February 15th, 2022|BLOG|

WHO IS THE CH REP?

Following the failure to achieve an institutional agreement between Switzerland and the European Union, Switzerland made the CH REP nominee compulsory. CH REP is a physical or legal person with registered office in Switzerland acting on behalf of Medical Devices Manufacturers based outside the Swiss territory. WHY IS THE CH REP FIGURE NECESSARY? The CH [...]

2021-10-08T14:08:41+02:00October 8th, 2021|BLOG|

Which acronyms and terms must a Quality&Regulatory professional know?

In the field of medical and in vitro diagnostic devices, being familiar with acronyms and most used definitions regarding Regulatory Activities and Quality is very important, if not vital, in order to communicate and work successfully. In every domain, some acronyms and terminologies used can be confusing for professionals, due to the overlapping among several [...]

2021-10-08T11:54:46+02:00October 8th, 2021|BLOG|

IVD: the MDCG publishes the IVDR Implementation and Preparation Plan (EU) 2017/746

In June 2021 the Medical Device Coordination Group (MDCG) published on the website of the European Commission the IVDR Preparation and Implementation Plan (EU) 2017/746 for in vitro Diagnostic-Medical Devices (IVD) “Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic Medical Devices (IVDR)”. The MDCG, with the input of the interested [...]

2021-09-07T11:16:28+02:00September 7th, 2021|BLOG|

European Authorised Representative, Swiss Authorised Representative and UKRP: roles and responsibilities

The regulatory regimes of the Old Continent are undergoing great change: the scenario is fairly heterogeneous and far from a standardization process. In particular with regard to the European Union, Switzerland and United Kingdom, the current regulation views Switzerland and the UK as Third Countries, no longer covered by the mutual recognition through which they [...]

2021-06-08T17:29:07+02:00June 8th, 2021|BLOG|

MDR: Switzerland becomes a Third Country in the Medical Device Sector

UPDATE 31/05/2021 Since 26 May 2021, with the full application of the Medical Device Regulation MDR (EU) 2017/745 and in the absence of an institutional agreement reached, Switzerland is officially considered a "Third Country" for Europe. This means that Swiss Manufacturers must appoint a European Authorised Representative to export their devices to Europe. At the [...]

2021-05-31T14:10:44+02:00May 31st, 2021|BLOG|

Adverse Events: what should MD and IVD Manufacturers do according to FDA?

In the United States, according to the Medical Device Reporting: Electronic Submission Requirements (eMDR), the Food and Drug Administration (FDA) requires Manufacturers of Medical Devices (MD) and In Vitro Diagnostic Medical Devices (IVD) selling in the U.S., to report any occurred or potential adverse events related to their Medical Devices. Adverse Events: what should MD [...]

2021-05-18T16:21:40+02:00May 18th, 2021|BLOG|

First MDR Certificate for 3DIEMME with the support of Thema

Great satisfaction for the 1st MDR Certificate obtained by 3DIEMME with Thema support With great pride and satisfaction, we communicate that our Customer 3DIEMME srl has obtained its first MDR (EU) 2017/745 certificate from the IMQ Notified Body for the RealGUIDE™️ 5.0 software, with the support of Thema experts. As part of Thema, we have [...]

2021-02-01T11:24:39+01:00February 1st, 2021|BLOG|
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