News

EU GDPR: Standard Contractual Clauses for Controllers and Processors

The European Commission, through its Implementing Decision (EU) 2021/915, adopted on  June 4, 2021, a set of Standard Contractual Clauses to be used between controllers and processors under Article 28(7) of General Data Protection Regulation (EU) 2016/679 (GDPR) and Article 29(7) of Regulation (EU) 2018/1725.

Transplants & medical devices: the Spanish Authority presents RENACER

A second chance, a second opportunity in life is what most organ-transplant receivers say they have been given. As human beings, we know our time is finite, yet thanks to science, technology, and years of research, we can now battle some fatal conditions. Nevertheless, there are certain risks involved. According

Conference on New Medical Devices Regulations (RMD)

With the many and ongoing changes due to the MDR and IVDR deadlines a lot is happening in the medical devices world, impacting other sectors as well. The 6th annual Conference on New Medical Devices Regulations organized by the European Association of Authorized Representative (EAAR) on the 2nd and 3rd

Congress on Regulations and Compliance for Cosmetics (CRCC)

For the 6th year consecutively the European cosmetics Responsible Person Association (ERPA) is organizing the annual Congress on Regulations and Compliance for Cosmetics. The event will be virtual given the global pandemic situation, with live Q&A sessions and will be taking place on 02.-03.02.2022 We

New cybersecurity obligations under Radio Equipment Directive (RED)

On October 29, 2021, the European Commission adopted a delegated act to the Radio Equipment Directive aiming at scaling up the cybersecurity of wireless devices and products for the benefit of consumers. The act establishes obligations for manufacturers, importers, and distributors to include new traceability features to ensure a higher

A reinforced role for the European Medicines Agency (EMA)

On October 28, 2021, the European Parliament and Council reached a provisional agreement to ensure the European Medicines Agency (EMA) will be more effective in monitoring and mitigating shortages of medicines and medical devices. As announced in the EU Parliament’s press release, the EU regulators agreed to introduce a

Cobalt in medical devices: French CA publishes a Q&A document

The French competent authority (ANSM) has published information for medical devices containing COBALT further to the publication of the Commission Delegated Regulation (EU) 2020/217 amending and correcting Regulation (EC) No 1272/2008 of the European Parliament and the Council on classification, labeling and packaging of substances and mixtures. This

MEDICA 2021: Obelis Team Was There!

Current trends, compliance pain points and regulatory updates discussed during MEDICA.Obelis Group was present at MEDICA 2021, the largest medical trade fair in the world, for the 18th consecutive year. The event took place in Dusseldorf (Germany) between November 15 and 18. MEDICA has been firmly established on our

Requirements for Legacy Devices under the MDR as of May 26, 2021

On May 26, 2021, the Medical Devices Regulation 2017/745 entered into application. This brought many implications for medical devices manufacturers, regardless of the class. We have previously covered MDR topics, such as how to achieve compliance for Class I medical devices and we will now address the requirements for

European Commission launches the High Level Construction Forum

On September 28, 2021, the European Commission launched the first meeting of the HLCF (High-level construction forum). More than two hundred representatives from the EU member states, stakeholders, social partners, and the European Commission took part in the exchange, addressing the HLCF’s main prerogatives. 1. The HCLF Aim The

European Parliament calls for action plan to phase out animal testing

On September 16, the European Parliament adopted a Resolution calling for an EU-wide action plan to phase out the use of animals in research and testing. While acknowledging the advances animal testing has had in developing treatments for human and animal health in the past, the Parliament underlines several shortcomings

The advantages of a common charger for the EU market

Innovation and rapid development are certainly two of the objectives that the European Union is trying to promote, together with the proposition of sustainable solutions to safeguard the future of the environment. For this reason, the European Commission is working on a proposal for amending the Radio Equipment Directive 2014/