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.
Canadian medical device legislation develops in the same direction as EU MDR
Anaplastic large cell lymphoma associated with a breast implant (BIA-ALCL) Report
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
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
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
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
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.
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
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!
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
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
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
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
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
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
European Commission has received 33 applications from NBs
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
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
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”
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
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
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
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
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
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
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
The Challenges of Designing a Mobile Medical App for Safe and Effective Use
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
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
ISO 13485:2016 strengthens the control of suppliers in the Medical Devices Industry
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)
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
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
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
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
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
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
In September 2017 the Belgian Competent Authorities of In Vitro Diagnostics merged with the Medical Devices authorities.
Medical apps under the new European MDR
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
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
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
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
Revised guidelines on first in-human clinical trial
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
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
By Davide Turchi – RA/QA Consultant
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?
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
EU Vote on First Borderline Decision: Cranberry Products Are Not Medical Devices
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).
Transition of Notified Body from NB0434 and NB0470 to DNV GL Nemko Presafe NB2460
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
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