Obelis' Newsletter April

OBELIS' NEWSLETTER

COVID self-tests in Belgium: Conditions and approval process

From April 4, 2021, rapid antigen self-tests are allowed for sales in Belgian pharmacies! However, only if they respect strict conditions set out and verified by the Belgian Competent Authority FAMHP.

IVD

Copper nanoparticles: SCCS’ opinion raises concerns for safety

In March 2021, the Scientific Committee on Consumer Safety (SCCS) published the opinion on the use of nano copper and nano colloidal copper in cosmetics, informing that the data provided is insufficient to conclude that the use of these particles is safe.

Cosmetics

The European privacy family & UK: towards an adequate level of personal data protection

The European Commission has published two draft decisions, one under the General Data Protection Regulation (GDPR) and the second one under the Law Enforcement Directive (LED).

GDPR

Call for data on ingredients with potential endocrine-disrupting properties used in cosmetic products

The COVID Starting from February 15^th, 2021, the European Commission launched a call for any interested parties to submit scientific information related to some cosmetic ingredients that may have potential endocrine-disrupting properties.

Cosmetics

The deadline for complying with the new Medical Device Regulation is coming!

As of the 26th of May, the following medical devices will need to comply with the MDR.

Class I devices, custom-made devices, systems & procedure packs will have to comply with all requirements set by the MDR as of the 26th of May 2021.

Legacy Devices – meaning devices that have a valid MDD CE Certificate from a Notified Body, or Class I devices that will be up-classified by the MDR – can enjoy the MAX 3 years grace period for transition, but still have to comply with certain MDR requirements as of the 26th of May 2021.

Should you have not initiated the MDR compliance procedure yet, contact us immediately.

As of the 26th of May, the following medical devices will need to comply with the MDR.

Class I devices, custom-made devices, systems & procedure packs will have to comply with all requirements set by the MDR as of the 26th of May 2021.

Legacy Devices – meaning devices that have a valid MDD CE Certificate from a Notified Body, or Class I devices that will be up-classified by the MDR – can enjoy the MAX 3 years grace period for transition, but still have to comply with certain MDR requirements as of the 26th of May 2021.

Should you have not initiated the MDR compliance procedure yet, contact us immediately.

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WEBINARS »

Software Classification, Compliance and MDR Review Process

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Interested in webinars? Let us know!

OBELIS'

NEWSLETTER

OBELIS'

NEWSLETTER

In this webinar we will provide an overview on:

MDR review processes for Software

Background and deadlines

Documentation review routes

Software Certification Process – Challenges of the EU MDR

In this webinar we will provide an overview on:

MDR review processes for Software

Background and deadlines

Documentation review routes

Software Certification Process – Challenges of the EU MDR

GET THE RECORDING!

Most recent EU regulatory updates on the use of cannabis ingredients in cosmetics

Alessandro Polimeno

#CBD

Alessandro Polimeno

#CBD

The regulatory domain of cannabis has been lately impacted by a number of international developments. Focusing particularly on the EU perspective, let us have a look at the most recent updates that have happened in the last six months.

SAVE THE DATE »

Follow our LinkedIn page to stay always up to date!

KIND REMINDER!

Due to the increase of Covid-19 cases in Belgium, the Belgian Government adopted new restrictions as for last Friday, March 26, 2021.

In light of the above, Obelis personnel is now teleworking with only limited staff present at the office. Therefore, we are very sorry, but we are not able to duly receive all phone calls and re-direct them to the consultant in charge of the specific matter.

We all hope to go back to normality as soon as possible, but in the meanwhile, we would like to kindly suggest you contact us via email to schedule a call via your preferred tool (Teams, Lifesize, Zoom, …).

Thank you very much for your understanding.

KIND REMINDER!

Due to the increase of Covid-19 cases in Belgium, the Belgian Government adopted new restrictions as for last Friday, March 26, 2021.

Thank you very much for your understanding.

WHAT'S NEW »

Obelis Vigilance card

Every product, sooner or later, will face an Undesirable Effect!

It is a legal obligation to inform the Competent Authorities about Serious Undesirable Effects!

Every product, sooner or later, will face an Undesirable Effect!

It is a legal obligation to inform the Competent Authorities about Serious Undesirable Effects!

REQUEST YOUR VIGILANCE CARD | COSMETICS

REQUEST YOUR VIGILANCE CARD | MEDICAL

WORKSHOP:

PERSON RESPONSIBLE FOR REGULATORY COMPLIANCE (PRRC)

WORKSHOP:

PERSON RESPONSIBLE FOR REGULATORY COMPLIANCE (PRRC)

This 2-day workshop on Person Responsible for Regulatory Compliance (PRRC) is intended to provide the initial concepts to those who are looking to understand the role of the PRRC. The training is provided by leaders in the industry that will provide you with an overview of the MDR/ IVDR.

In collaboration with SYNC POJECTS

Medical Device Regulation and Artificial Intelligence: what future requirements?

The Special Committee on Artificial Intelligence in a Digital Age (AIDA), established by the European Parliament, has directed all its efforts in filling current regulatory gaps to develop a European framework on Artificial Intelligence (AIDA, 2021).

Medical

Safety Gate: the key to Consumer Protection

Safety Gate is the tool used by national authorities of 31 countries (EU/EEA Member States and the UK) to notify the European Commission of non-food products that pose a serious risk to the health and safety of consumers.

Medical

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