Obelis.net

Healthcare Obelis.net

WebHealthcare. Healthcare is one of Obelis’ main points of expertise, managing both the Medical Devices Regulation 2017/745 (MDR) and the In Vitro Diagnostic …

Actived: 5 days ago

URL: https://www.obelis.net/industries/healthcare/

Medical Device Regulation and Artificial Intelligence: what

WebThese closely resemble the requirements under the Medical Device Regulation and include: Appointment of Authorized Representative; Quality Management …

Category: Medical Go Health

National Registration for medical devices Obelis.net

WebSome categories of medical devices are mandatory to be registered with the French Agency for the Sanitary Security of Health Product (AFSSAPS), at the time of being put into …

Category: Medical Go Health

Final opinion on the Safety of Medical Devices containing DEHP

WebAfter months of public consultation, The Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) has now published the final Opinion on …

Category: Health Go Health

MedTech Europe: The value of digital health in the European …

WebA. Belgium: Belgium recently introduced a “Provisions for national funding or reimbursement of digital health applications” system.In February, the National Institute …

Category: Health Go Health

Your Trusted Partner for Global Regulatory Compliance

WebExperience. Founded in 1988, we are among Europe’s largest centres for advisory and representative services. ISO Certification. We are certified by ISO 9001:2015 and ISO …

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New Guidance on classification has been published

Webon April 7, 2010. The NEW Guidance Document (MEDDEV) on the classification of Medical Devices has been published by the European Commission, DG HEALTH AND …

Category: Medical Go Health

HPRA alert on dangerous Melanotan 2 in self-tanning products

WebOn June 27, 2022, the Health Products Regulatory Authority (HPRA) published an alert about the serious health risks linked to the substance Melanotan 2. The HPRA is the …

Category: Health Go Health

The road to EU compliance

WebWe will notify your products on the Cosmetics Products Notification Portal (CPNP) in 1 day! We liaise directly with your producers, sign a NDA and gather all the documentation. We …

Category: Health Go Health

FDA vs. EU compliance under the new Medical Device Regulation

WebFDA vs. EU compliance under the new Medical Device Regulation. on April 10, 2015. The recently adopted Medical Device Regulation 2017/745, set as an …

Category: Medical Go Health

What is changing for IVD Classification under the new IVD …

WebMany manufacturers may very well already be feeling the benefits of the new EU IVD Regulation 2017/746. Approved on April 5 th of this year, and in force as of May …

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Surveillance activities of medical devices in Italy: First report of

WebThe 2018 Report. The Report analyzes data from 2018, as recorded by the system of national surveillance on medical devices (in-vitro diagnostic medical devices …

Category: Medical Go Health

Incidents defined under the new Medical Device Regulation

WebIncident: An incident is simply defined by the regulation as a ‘malfunction or deterioration’ in the function or aesthetic of a product as well as unclear, unprovided, or …

Category: Health Go Health

French CA issues procedure deal with risks of rupture of essential

WebThe French National Agency of Medicines and Health Products Security (ANSM) has recently published a special management procedure for market operators to …

Category: Medicine Go Health

Obligation on icons and symbols to display for manufacturers

WebReferences: · European Commission..(2022). COMMISSION IMPLEMENTING DECISION (EU) 2022/6 amending Implementing Decision (EU) …

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Finnish Medicines Agency Takes Over Medical Device Regulation

Webon February 25, 2020. At the beginning of 2020, Fimea, the Finnish Medicines Agency, took over the supervision of medical devices, operators and device trials from Finland’s …

Category: Medical, Medicine Go Health

European Commission investigates the safety of Metal-on-Metal …

WebThe European Commission asked the Scientific Committee on Emerging Newly Identified Health Risks (SCENIHR) for a scientific opinion to assess the safety of …

Category: Health Go Health

Promotion & advertising rules for Medical Devices by EU Directives

WebThe Medical Device Directive 93/42/EEC provides the following basic provisions: Only CE marked medical devices may be promoted and placed on the market …

Category: Medical Go Health

Medical Device Industry: Switzerland becomes a “third country”

WebThe impact of the missing update of the MRA as of May 26, 2021. The European Commission has pointed out important changes for stakeholders in a …

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Italy Registration Update: Class I Medical Devices

WebBackground. According to Italy’s Decree of Feb. 20, 2007, all classes of medical devices introduced in Italy after May 1, 2007 must be registered in the Italian …

Category: Medical Go Health

Implementing a GMP for Cosmetics

WebObelis Group +32 (0) 2 732 59 54 [email protected] Registered address Bd Général Wahis 53 B-1030 Brussels, Belgium Registered office address Boulevard Brand …

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EU Court rules on Cosmetics Labelling and importance of

WebIn December 2020, the Court of Justice of the European Union (CJEU) delivered a preliminary ruling on the interpretation of the requirements applicable to the …

Category: Health Go Health