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
European Commission has received 33 applications from NBs
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
New countries admitted to the Hague Conference
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
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
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.
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.
The new South African Health Products Regulatory Authority (SAHPRA)
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
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
NEW devices covered by the IVD Regulation
The future role of Eudamed
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
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) ?
The role of distributors under the new Medical Device Regulation
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.
The New Clinical Trial Regulation & Its Benefits
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
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
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
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.
Obelis 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