The NB-MED recently published the results of a survey performed between 2018 and January 2019 on the applications of Notified Bodies to be designated under the IVDR.
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NB-MED Performed a survey on IVDR Readiness of the Notified Bodies.
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Support Point-of-Care Scanning of UDI Data for Implantable Devices: new GS1 guidance
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Standards development organization ISO Standards on packaging for terminally-sterilized medical devices (2019 Update)
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International Organization for Standardization (ISO) published revised standards on packaging for terminally sterilized medical devices. The creation of appropriate standards is crucial to achieve that the development, validation of packaging processes as well as the device components and the packaging system ‘’create sterile medical device that performs efficiently, safely and effectively… and ensure that sterile barrier system integrity is attained and will remain so until opened by the users… ’’.
Canadian medical device legislation develops in the same direction as EU MDR
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Regulatory frameworks of medical devices have been under scrutiny in several major export markets including the EU and Canada. In Europe, legislators have been laying down more stringent regulatory requirements with aim of improving the safety and performance of medical devices on the market. In comparison to the current legislative set-up, the new EU medical device regulation has a more risk-based approach.
Anaplastic large cell lymphoma associated with a breast implant (BIA-ALCL) Report
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Breast Implant-Associated Anaplastic Large Cell Lymphoma(BIA-ALCL) is a rare type of non-Hodgkin lymphoma that can appear as a mass adjacent to the breast implant or a delayed periprosthetic seroma. Studies done so far, suggest that women with breast implants may have a very low but increased risk of developing this type of lymphoma. The current estimate is that there are approximately 600 reported cases of BIA-ALCL worldwide.
Commission’s communication campaign on MDR and IVDR – special notice to manufacturers
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European Commission takes initial but crucial steps in efficiently communicating the changes brought by the Medical Device Regulation (EU) 2017/745 (MDR) and the In vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR).
MHRA Official Guidance on How Medicines, Medical Devices and Clinical Trials Would Be Regulated If There’s No Brexit Deal
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March 29th 2019 is fast approaching, and the UK is currently facing to leave the EU without a deal in place. For this reason, the UK government has been publishing technical notices for businesses and citizens to understand what to expect in a no deal scenario. We will focus on the recently published MHRA official guidance with regard to the regulation of medicines, medical devices and clinical trials in case there is no Brexit deal. Find below the most remarkable points:
The prohibition of misleading claims arising from Article 7 MDR was implemented as a criminal offence in the Netherlands
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As we all know, the Medical Device Regulation (EU) 2017/745 will be fully implemented as of May 2020 and concerns are being raised not only about the requirements of the new regulation but also on the implementing acts of the Member States.
“Equivalence” under the New EU MDR
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Clinical evaluation occupies a significant role in the new regulatory framework and appears in several sections of the Medical Device Regulation (MDR).
Among the most complex aspects is the term ‘equivalence’, which – if demonstrated – would exempt manufacturers of high risk devices from performing costly and lengthy clinical investigations. However, certain conditions need to be met. The MDR in fine shrinks the possibility to rely on the ‘’equivalence’’ of clinical data of already marketed devices in the EU.
NEW VERSION OF THE BORDERLINE AND CLASSIFICATION MANUAL FOR THE MEDICAL DEVICES AND IVDs.
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On October 30th, the European Commission published a new version (Version 1.20) of the Borderline and Classification Manual for Medical Devices and In-vitro Medical Devices for the second time in 2018. The manual aims to facilitate the interpretation of the Medical Devices Directive (MDD) with regard to classification and borderline medical devices.
Registration of medical devices in Slovakia
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Placing your medical device into the European market is contingent upon your compliance with the Medical Device Directive (93/42/EEC). While this Directive is a law to all 28 member states within the European Union, each member state has its own way of implementing the Directive within their country, essentially adding regulations to the Directive and creating Local Legislation. Read more
Obelis UK Ltd established!
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We are happy to inform you that on 27th of December Obelis has officially established a new company in the UK – Obelis UK Ltd. The purpose of this company is to serve as a UK Responsible Person for our clients, who will need a representative in the UK in the case of a ‘no deal’ Brexit. Read more
New MDR Conformity Assessment Routes
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The approaching EU Medical Device Regulation – which will become applicable on 26 May 2020 – puts great emphasis on the assessment of product safety and performance by placing stricter requirements on clinical evaluation, post-market clinical follow-up and traceability of devices. Thus, the manufacturers worldwide need to perform some crucial adjustments in order to become compliant with the new law. Read more
New updates on the state-of-the art thinking on UDI system and database
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The implementation of a new device identification system based on a Unique Device Identifier (UDI) is starting to become a reality. Since the New Regulations concerning medical devices were adopted on April 2017, the Medical Device Coordination Group (MDCG) and the EU UDI Working Group (UDIWG) have been drafting some guides on this topic. Read more
New version of EN ISO 10993-1:2008
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The ISO 10993 (Biological Evaluation of medical devices) sets out a series of standards for evaluating the biocompatibility of medical devices. Its primary aim is the protection of humans from potential biological risks arising from the use of medical devices and its primary role is to serve as a framework in which to plan a biological evaluation. Read more
PVCs in medical devices
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The Medical Device industry has suffered tremendous changes during its long life, evolving parallel to medicine discovering and technology developments. Read more
The Medical Device Coordination Group gives guidance on the UDI database for the particular cases of Systems and Procedure Packs and Medical Device Software
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According to the Medical Device Regulation (MDR) which is about to be fully implemented, systems and procedure packs will be subject to certain obligations in order to be compliant with the legislation. Read more
Spanish Database for Medical Devices and IVD registration changed
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To market Medical Devices 93/42/EEC and the IVDs 98/79/EEC in Spain, in addition to the Directive requirements, the related Spanish transposition Law also previewed a National Registration Process. Read more
European Commission has received 33 applications from NBs
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Due to the new Medical Devices and In-Vitro Diagnostics Regulations, Notified Bodies will have new responsibilities meaning that they must obtain accreditation to certify medical devices under the New Regulations. To do so, Notified Bodies are requested to send a designation application to the Competent Authorities and will then be assessed and audited by the European Commission and National Competent Authorities. Read more
Spanish, Croatian and Bulgarian registration of Medical Devices and IVDs
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It is well known that the Medical Devices 93/42/EEC and the IVD 98/79/EEC Directives are leaving space to National Competent Authorities regarding the application of the Laws, and also the eventual imposition of additional requirements when possible. One of the typical examples is the imposition of a National Registration Process.
Class I MDR requirements – Chapter 1 – Clinical Data
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Clinical data is the information derived from the use of medical devices that pertains to the devices’ safety and performance. Therefore, clinical data is presented as evidence of these two aspects being fulfilled as well as for conformity assessment purposes. Such data, can be generated following two different paths:
Team-NB position paper on “Points to add to contracts between Manufacturers and notified bodies”
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Team-NB has prepared a template of contractual clauses that shall be added to the Agreement that the Manufacturer has concluded with his Notified Body to be applicable in the transition period of MDR and IVDR. This is particularly relevant for the Manufacturers who will be using CE Certificates issued under the ‘’old’’ regime of the Directives after the new Regulations become applicable, but until May 2024 at the latest.
Obelis visiting FIME in Orlando
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Obelis does not hesitate to attend the most important exhibitions around the world!Medical devices and health products from more than 600 companies were on display to the world in the 28th FIME edition. This year’s exhibition took place on 17-19 July 2018 and has changed from the traditional location in Miami to Orlando.
CAMD and MDR/IVDR transitional provisions
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The EU Competent Authorities for Medical Devices (CAMD) is the platform which assembles the national competent authorities for medical devices in Europe. The main objective of CAMD is to improve cooperative efforts, enhance post-market surveillance and boost communication in the medical device sector across the European Union.
MDR Notice for Class I Manufacturers
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The Medical Device Regulation (EU) 2017/745 (MDR), published in May 2017 with a transitional period expected to end on May 26th 2020 – From that date, the Regulation will apply in full.
There is no provision for “grandfathering” within the Regulation. Meaning, all devices will need to comply with the MDR and shall be subject to the appropriate conformity assessment (re-certification) procedure under the MDR.
Devices which a conformity assessment procedure under Directive 93/42/EC did not require them to obtain a notified body certificate – will need to comply with the Regulation as of May 26th 2020!
Investigating a Medical Device Complaint
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There are no predefined rules in determining to what extent a manufacturer should investigate a medical device complaint, but there are several key facts and questions that may be used as a guidance.
Switzerland aligns medical devices legislation to future EU Regulations
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The quality and safety of medical devices ensured by a better control of the market and stricter rules in general convinced Swiss legislator will promptly follow the future EU regulatory framework on medical devices (MDR/IVDR). The alignment is also required by the signature of the agreement between the EU and Switzerland on the mutual recognition of conformity assessments.
New Electronical Apostille system from the Belgian Ministry of Foreign affairs
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In May 2018 the Belgian Ministry of Foreign Affairs has changed the procedure of the legalization of the Free Sales Certificates. For the countries which are part of the Hague Convention of 5 October 1961 Abolishing the Requirement of Legalisation for Foreign Public Documents, from now on FSC’s will be legalized with new Electronical Apostille from the Ministry.
The “sell off” provision under the MDR and IVDR
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The EU Competent Authorities for Medical Devices The Challenges of Designing a Mobile Medical App for Safe and Effective Use
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As application designers have begun taking advantage of the advancements of technology and the growing patient trend for self-diagnosis and treatment, regulators have begun scrutinizing mobile medical apps.
Belgian Medical Competent Authority abolishes submission taxes
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It is well known that the Medical Devices 93/42/EEC and the IVD 98/79/EEC Directives are leaving space to National Competent Authorities regarding the application of the laws, and also the eventual imposition of additional requirements when possible. One of the typical examples is usually represented by the provision of Official taxes to be paid prior to or post submission of official documents related to specific procedures (e.g. Registrations, Notifications, Free Sales Certificates).
The impact of the new MDR and IVDR Regulations on Notified Bodies
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The new MDR (2017/745) and IVDR (2017/746) will replace the EU’s current Medical Device Directive (MDD) (93/42/EEC) and In Vitro Diagnostics Directive (IVDD) (98/79/EC) to establish a more robust EU legislative framework and ensure better protection of public health and patient safety.
ISO 13485:2016 strengthens the control of suppliers in the Medical Devices Industry
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The 2016 revision of the ISO 13485 standard introduces a more stringent approach to the control of critical suppliers. The concept of supplier control is not new to ISO 13485; as it is already widely applied in regulatory schemes including the Medical Devices Sector. The revision will however affect the manufacturers who are subcontracting critical parts of the production process and significantly increase their duties.
Clinical Evaluation for medical devices (new requirements under MDR)
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With the aim to ensure a higher level of health and safety through transparency and traceability of medical devices, the new MDR requirements on clinical evaluation are expected to be the greatest challenge for manufacturers of medical devices.
Saudi Arabia – SASO and CAP (Conformity Assessment Program) do not apply to Medical Devices – FSC is the best tool to enter this market
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SASO CoC (Certificate of Conformity) and CAP (Conformity Assessment Program) are two particular Conformity Assessment routes that are allowing manufacturers worldwide to enter the market of Saudi Arabia with their products. This is in order to ensure some key objectives such as: Protection of public health, Consumer safety, National security, Protection of religious and public morals and environment, Prevention of deceptive practices.
Electronic cigarettes are to be regulated as medical devices if they do not contain nicotine
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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?
Post-market surveillance under the MDR: New requirements
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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).
Sanitary Certificates in Italy
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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.
The differences of ‘intended use’ and ‘instructions for use’ in medical devices
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In medical devices as well as in-vitro diagnostic devices the meanings and objectives of ‘’intended use/purpose’’ and ‘’instructions for use’’ are different:
- 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
- ‘’Instructions for use’’ direct the user towards the appropriate use of the device.
Why does the differentiation between the two terms matter?
Merger of Belgian IVD & MD authorities
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In September 2017 the Belgian Competent Authorities of In Vitro Diagnostics merged with the Medical Devices authorities.
Medical apps under the new European MDR
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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).
EU Clinical Trials Database Delayed Until 2019
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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.
The importance of GMDN Codes
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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.
New EU Borderline and Classification Manual on Medical Devices
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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.
New European Notified Body Product Codes Open for Consultation
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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.
Revised guidelines on first in-human clinical trial
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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.
Upcoming changes in Medical Devices Regulation in Australia
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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.
Notified Bodies intention to submit designation application MDR and/or IVDR
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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.
Are E-Cigarettes regulated as Medical Devices?
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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?
Newly defined devices under the IVDR
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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
