News

Electronic cigarettes are to be regulated as medical devices if they do not contain nicotine

in News

Electronic cigarettes are generally used for two purposes: either to help with the treatment of nicotine dependence or to serve as a replacement. When used for treatment, such products can be seen either as medicinal products or as medical devices – but how can a manufacturer decide on the classification of their electronic cigarettes?

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Post-market surveillance under the MDR: New requirements

in News

The manufacturer’s obligation to proactively collect and review experiences obtained from medical devices already circulating on the market, and to apply any necessary preventive and corrective measures; or in other words post-market surveillance (PMS), is strengthened under the new Medical Devices Regulation (MDR).

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Sanitary Certificates in Italy

in News

In order to protect public health, shipments of goods of medical interest imported from third countries and arriving at the international entry points of the Italian territory are subject to controls by the National Medical Authority.

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The differences of ‘intended use’ and ‘instructions for use’ in medical devices

in News

In medical devices as well as in-vitro diagnostic devices the meanings and objectives of ‘’intended use/purpose’’ and ‘’instructions for use’’ are different:

  1. The ‘’intended purpose” of a device is a claim stated on the label for which the device was designed and determines for which medical purpose the device can be used, while
  2. ‘’Instructions for use’’ direct the user towards the appropriate use of the device.

Why does the differentiation between the two terms matter?

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Merger of Belgian IVD & MD authorities

in News

In September 2017 the Belgian Competent Authorities of In Vitro Diagnostics merged with the Medical Devices authorities.

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Medical apps under the new European MDR

in News

The proliferation of mobile devices and health care-related mobile applications is radically changing the way health care services are delivered. These health apps range from calorie counters and pedometers to blood glucose monitors and remote electrocardiogram (EKG) monitoring, which may also be connected to an electronic health record (EHR).

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EU Clinical Trials Database Delayed Until 2019

in News

According to the statement of the Management Board of the European Medicines Agency, the implementation of the Clinical Trials database will be delayed until 2019 due to technical difficulties.

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The importance of GMDN Codes

in News

The General Medical Devices Nomenclature (GMDN) which has been developed based on EN ISO 15225:2000 nomenclature is crucial concerning the European Databank (EUDAMED). GMDN codes are being managed by the GMDN Agency and have the form of a five digit number.

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New EU Borderline and Classification Manual on Medical Devices

in News

The Working party on borderline and classification – including the European Commission – recently issued the new version of the Manual on borderline products, i.e. unclear whether the product is covered by the Medical Device/IVD Directive or not; and on classification of medical devices, i.e. uncertainty regarding the class of a medical device.

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New European Notified Body Product Codes Open for Consultation

in News

Introduction

A public consultation was opened last week about the first implementing act related to the Medical Devices and IVD EU Regulations. The act concerns the Notified Body (NB) product codes used to categorize the fields of expertise of the NBs and thereby define their scope.

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Revised guidelines on first in-human clinical trial

in News

On 1st February 2018, after the review of the EMA (the European Medicines Agency) with the contribution of the European Commission and the representatives of the EU Member States through the EU Clinical Trials Facilitation Group (CTFG), the new guidelines on first-in-human clinical trials will enter into force. The in-human clinical trials represent a turning point in medical development. Medicines already tested in vitro and on animals will be administered to humans for the first time.

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Upcoming changes in Medical Devices Regulation in Australia

in News

For a medical device to be legally supplied in Australia, it must be included in the Australian Register of Therapeutic Goods (ARTG), which is regulated by the Australian Therapeutic Goods Administration (TGA).

The Australian Therapeutic Goods Administration (TGA) currently recognises CE marking, which means that companies that have already acquired market access in Europe can also easily meet the TGA regulatory requirements.

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Notified Bodies intention to submit designation application MDR and/or IVDR

in News, Uncategorized

By Davide Turchi – RA/QA Consultant

 

Introduction

Without any doubts, Notified Bodies are a particular type of entity that is highly affected by the new Medical Devices and In-Vitro Diagnostics Regulations. Notified Bodies will be strictly assessed and audited by the European Commission and National Competent Authorities in order to receive accreditation to certify medical devices under the New Regulations.

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Are E-Cigarettes regulated as Medical Devices?

in News

Electronic cigarettes work by heating up a liquid until vaporization is reached. This is essentially another way of putting nicotine into your body. How are electronic cigarettes being regulated under EU Law? Are these to be considered as tobacco products or something else?

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Newly defined devices under the IVDR

in News

With the new EU IVD Regulation 2017/746 entering into force on 26th May 2017, in vitro diagnostic medical devices will no longer be classified with a list-based approach, but instead (and similarly to the Medical Devices Directive 93/42/EEC) with a risk-based approach. Read more


EU Vote on First Borderline Decision: Cranberry Products Are Not Medical Devices

in News

On 19th May, 2017, The European Commission’s Regulatory Committee on Medical Devices adopted the European Commission’s decision on the qualification of cranberry products, which states that cranberry products are not medical devices. This vote came more than one year after the draft decision issued in February 2016, and it is the first borderline decision adopted based on MDD Article 13(1)(d).

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Transition of Notified Body from NB0434 and NB0470 to DNV GL Nemko Presafe NB2460

in News

DNV GL Business Assurance Norway AS NB 0434 ceased to operate in May 2017 and so did Nemko AS NB 0470 in April 2017. Both aforementioned Bodies were operating as a joint venture which merged with the aim of transitioning their departments under one new legal entity and because of the mandatory renewal of designation for all Notified Bodies under the new Medical Devices Regulation MDR 2017/745. Read more


Products without medical purpose within the scope of MDR

in News

The new EU Medical Devices Regulation 2017/745 (MDR) officially entered into force on 25th May 2017 amending the Directive 93/42/EEC and will be fully applicable after a transition period of three years (2020). One of the most relevant changes introduced by the new Regulation lies in the extension of its scope, now including certain “products without an intended medical purpose”. Read more


New countries admitted to the Hague Conference

in News

Four new countries: Dominican Republic, Colombia, Kazakhstan and Lebanon, have been admitted to the Hague Conference on Private International Law. This achievement will facilitate the commercial and political relationship with the member states of the above mentioned organization. Read more


New Responsibilities of EAR under the new MDR

in News

The New EU Medical Devices Regulation 2017/745 has entered into force on May 25th with a transition period of 3 years, setting the date of application on May 26th  2020. While manufacturers shall use the transition period to update their technical documentation and processes in order to meet the new requirements, European Authorized Representatives (E.A.R.) have to be also ready to meet their new obligations. Read more


The new EU UDI codes for Medical Devices

in News

On the 5th of April 2017, two New Regulations concerning medical devices were adopted by the European Parliament. They will replace the current Medical Devices Directive 93/42/EEC, Active Implantable Medical Devices Directive 90/385/EEC and In-Vitro Diagnostic Directive 98/79/EC.

Newly issued Medical Devices Regulation implements new device identification system based on a Unique Device Identifier (UDI). UDI system was developed in the United States in 2007, and since then, it has been successfully implemented.

As the European Commission acknowledged the success of UDI system in the United States, in 2013 it issued recommendation concerning implementation of the new system also in the EU. Now with the New Medical Devices Regulation coming into force, this implementation is becoming a reality.

What are the advantages of UDI system?

  • Improved transparency of the medical device traceability,
  • Preventing fraud by the strengthened surveillance of all medical devices on the EU market,
  • Public access to medical devices data,
  • Reduction of errors and malfunction of the devices entering EU market, what directly improves patients’ safety.

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If you wish to know more about the UDI system, please do not hesitate to contact us. Obelis Expert Consultants, having nearly 30 years of experience with EU Regulations, will gladly answer any question you may have and will assist you in safeguarding your products’ compliance.

Szymon Nowak-Rogozinski


The new South African Health Products Regulatory Authority (SAHPRA)

in News

The South African government has formed an independent, state-owned agency to oversee new medical device and pharmaceutical regulatory systems being developed in the country. The South African Health Products Regulatory Authority (SAHPRA), which has been launched officially in June 2017, will be built up over the next few years, and will regulate both the medicines and the medical devices (including IVDs). Read more


Overview of CE Certification in 2016

in News

Team NB, The European Association of Notified Bodies, released a summary of the Medical Device Sector survey. It gives insight into the number and types of CE and ISO certificates issued or withdrawn for Medical Devices, In-Vitro Diagnostic Devices and Active Implantable Medical Devices in 2016. Read more


New EU MDR: no grandfathering rule

in News

On the 5th of April 2017 two New Regulations concerning medical devices were adopted by the European Parliament. They will replace current Medical Devices Directive 93/42/EEC and In-Vitro Diagnostic Directive 98/79/EC. Read more


NEW devices covered by the IVD Regulation

in News

 

The new EU IVD Regulation 2017/746 has been approved on 5th of April 2017 and it came into force on May the 26th2017. One of the crucial changes brought about by the new Regulation is the enlarged field of devices’ types covered by the new dictum. Read more


The future role of Eudamed

in News

With the newly published Regulations entering into force on the 25th of May, it is now essential to understand the importance of the Eudamed (European Database on Medical Devices) in the European medical device regulatory system. Previously accessible solely to Competent Authorities and the European Commission,  the new database aims not only at providing a wider accessibility, but also more information and of higher quality, such as traceability of medical devices, information on conformity assessment procedures, certificates, incidents and clinical studies. Read more


Potential Impact of Brexit over Authorized Representatives

in News

The Formal Procedure has begun

The UK has officially started the withdrawal procedure of their EU Membership by delivering the formal letter invoking Article 50 TEU on the 29th of March 2017. Complex negotiations will follow with a tight deadline of two years to settle various regulatory issues. What are the possible consequences involved for the European Authorized Representatives (EAR) ?

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The role of distributors under the new Medical Device Regulation

in News

On 5th April 2017 the European Parliament published an official press release announcing that New Medical Devices and In-Vitro Diagnostics Devices Regulations have been finally adopted. The final texts of the new Regulations were published in the Official Journal on 5th May 2017. With the adoption of the Medical Devices Regulation the obligations of the EU distributors will significantly change in comparison with the current legislative regime.

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The New Clinical Trial Regulation & Its Benefits

in News


 
 
 
 
 
 
 
 
The Clinical Trial Regulation will come into operation in 2018 and replace the existing EU Clinical Trial Directive (EC) No. 2001/20/EC. This regulation will change the way clinical trials are conducted in the European Union (EU) by harmonizing the assessment and supervision processes for clinical trials throughout the EU via an EU portal and database which will be maintained by the European Medicines Agency (EMA) in collaboration with the Member States and the European Commission. EMA will make information stored in the database publicly available subject to transparency rules. Read more


Obelis attends GLAM Consortium Meeting

in News

Obelis Chief Compliance Officer, Mrs. Sandra Ferretti, and Senior Regulatory Expert, Mrs. Louise Olliver, attended GLAM consortium meeting, which took place between 18th and 19th May 2017. GLAM is a European Union funded project for development of innovative In-vitro diagnostic devices. The meeting was held at Novellic – Belgrade, one of the consortium partners, who in charge of manufacturing the prototype of the laser multiplex device detecting various cancers, all in one testing procedure, as well as serving as companion device.  Read more


It is official: New EU MDR & IVDR enter into force

in News

On 5th May 2017, the new EU Medical Devices and In-Vitro Diagnostics Devices Regulations have been finally published in the Official Journal of the European Union. This means that the new Regulations will officially enter into force 20 days after their publication (hence on 25th May 2017) and replace currently existing directives MDD 93/42/EEC, AIMD 90/385/EEC and IVDD 98/79/EC. Read more


New Medical Devices & IVD Regulations adopted by the European Parliament

in News

On 5th April 2017 the European Parliament published an official press release announcing that New Medical Devices and In-Vitro Diagnostics Devices Regulations have been finally adopted. This vote is the final step in the long-lasting process to update existing MDD & IVD legislations, which started in the 90s. Final texts of new Regulations are expected to be published in the Official Journal in May 2017.

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Obelis at Medica 2016

in News

Obelis at Medica 2016Obelis at Medica 2016

Obelis Group exhibited for the 13th consecutive year at Medica Trade Fair, one of the biggest medical industry fairs in the world. The exhibition took place in Messe Dusseldorf (Germany) between 14th and 17th December 2016. Obelis’ team, comprised of 13 experts, offered free EU Compliance Consultancy sessions, ran an EROMED seminar and met with Obelis clients. Read more


Obelis to hold EROMED seminar at MEDICA 2016

in News

European Regulation of Medical Devices

Obelis Group will hold an EROMED seminar at the MEDICA trade show, taking place from the 14th November till 17th November in Messe Düsseldorf, in Germany. The seminar, which is entirely free of charge, will be conducted at the Obelis booth (Hall 17, Stand D59), every day at 11 am and 3 pm. It will focus on the new proposal on EU legislation on Medical Devices and its impact on the compliance path and the CE marking process. Read more


Obelis Attends Inauguration of CURAM (Center for Research in Medical Devices)

in News

Centre for Research in Medical Devices

Obelis Chief Compliance Officer, Mrs. Sandra Ferretti, participated in the official inauguration of CURAM – Center for Research in Medical Devices, which took place on Monday, the 26th of September 2016 in Galway, Ireland. The event, co-organised by Dr James J. Browne, the President of NUI Galway and Professor Abhay Pandit, the director of CURAM, brought together world-class academic, medical devices industry and clinical partners. Read more


MEDDEV 2.7/1 – new guidelines on clinical evaluations

in News

obelismedical

On the 29th of June 2016, the European Commission released a new version of MEDDEV 2.7/1, entitled “Clinical Evaluation: A Guide for Manufacturers and Notified Bodies under Directive 93/42/EEC and 90/382/EEC”. The recently issued file replaces the 2009 version. It outlines clear guidelines for both manufacturers and Notified Bodies on how to conduct a clinical evaluation of medical devices. Read more


EU to release NEW Medical Device Regulations!

in News

obelisarticle

In June 2016, the European Parliament released the consolidated texts of the new EU Regulation Proposals on Medical Devices and In-Vitro Diagnostics Devices. The texts, published on the European Parliament website, reflect the position agreed by the European Parliament and the Council of the European Union.

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New Medical Devices and In-Vitro Diagnostic Regulations – Status of the Ongoing Discussions

in News

The approval of the new EU Regulations on Medical Devices and In-Vitro Diagnostics Devices will be postponed to 2016. Read more


Obelis Launches a Bulgarian National Registration Service

in News

In accordance with the Law on Medical Devices, adopted by the Bulgarian Parliament during its session on June 12, 2007, and as promulgated in the Bulgarian State Gazette No. 46, some categories of medical devices must be registered with the Bulgarian Drug Agency (BDA). This registration is mandatory for medical devices that enter the EU internal market through, or if they are being manufactured in, the territory of Bulgaria.

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Common Approach on the Medical Devices Legislative Package

in News

On October 5, 2015, the Ministers of the EU countries agreed, after almost three years of discussions, on a general approach on the medical devices legislative package. This agreement is a major step towards ratification of new regulations on medical devices and in vitro medical devices that would ensure a higher level of health and safety protection for EU citizens as end users of these devices.

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Obelis Launches the Croatian National Registration Service

in News

As of June 18, 2013, all Medical Devices Class IIa, IIb, III, Active Implantable Medical Devices (AIMD) and In Vitro Diagnostic Medical Devices (IVD) marketed in Croatia must be registered with the Croatian Agency for Medicinal Products and Medical Devices (HALMED). Read more


New List of MDD Harmonized Standards Published by the European Commission

in News

On July 10, 2015, new harmonized standards under the Directive 93/42/EEC for Medical Devices were published for the first time.

These new standards include:

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Commission Opinion on Prohibiting the Use of Permanent Dermal Fillers for Aesthetic Purposes

in News

On July 11, 2014, the Dutch authorities notified the European Commission of the draft decree amending the Medical Devices Decree (Besluit Medische Hulpmiddelen), which aims to prohibit the use of permanent dermal fillers for anything other than reconstructive purposes.

On July 22, 2015, the European Commission published an Opinion about this measure. Read more


Electronic File Submission to the Belgian Agency for Medicines and Health Products

in News

Notification files for Class I Medical Devices, kits and procedure packs can currently be submitted in an electronic format to the Belgian Federal Agency for Medicines and Health Products (FAMHP).

The completion of the Notification procedure constitutes a prior condition to ensure the compliancy of Medical devices with the essential requirements of the MDD Directive; and therefore is a necessary step in order to affix the CE marking and sell the devices freely within the EU Market. Read more


Reference countries for FREE SALES CERTIFICATE

in News

A Free Sales Certificate (FSC) also referred to as “Free Trade Certificate” or “Certificate for Export” is an international export document. The certificate is intended to serve as evidence that the goods (medical devices, cosmetics, pharmaceuticals, etc.) meet the health and safety requirements of the exporting market and can therefore be made available on the importing market. Read more


Final Opinion on the Safety of Medical Devices containing DEHP (phthalate)

in Industry News Medical Devices, News

After months of public consultation, The Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) has now published the final Opinion on the safety of medical devices containing DEHP-plasticized PVC or other plasticizers on neonates and other groups that are possibly at risk. Read more


IMDRF proposes QMS Principles for Software as a Medical Device

in Industry News Medical Devices, News

In April 2015, the International Medical Device Regulators Forum (IMDRF) released a new guidance document on the application of Quality Management Systems (QMS) for software as a Medical Device (SaMD). Public consultation was open until 2015 June and final document is supposed to be published in October 2015. Read more


EU Council agrees on a General Approach for Medical Devices and IVDs Regulations

in Industry News In-Vitro Diagnosis, Industry News Medical Devices, News

On 19 June 2015 the Council of the European Union reached a general consensus on two draft Regulations aimed at modernising EU rules on Medical devices and In vitro Diagnostic Medical Devices. These new Regulations, once adopted, will replace the current MDD 93/42/EEC and IVDD 98/79/EC directives. Read more


Europe moves forward on New and Emerging Technologies

in News

The New and Emerging Technologies (NET) Working Group is following all the new and emerging technologies, and their impact in the field of medical devices at EU Commission level.  Read more


New EU Rules on Human Tissues and Cells

in News

On April 8th 2015 the European Commission adopted new rules aimed at ensuring high standards of quality and patient safety regarding human cells and tissues distributed in the European Union. Read more