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
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
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
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
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 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
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
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
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
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
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) ?
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 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 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
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
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 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 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 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
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
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.
The approval of the new EU Regulations on Medical Devices and In-Vitro Diagnostics Devices will be postponed to 2016. Read more
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.
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.
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
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:
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
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
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
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
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
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
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
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
Germany’s Federal Supreme Court is currently seeking clarity from the Court of Justice of the European Union (CJEU) on the liability and responsibilities of Notified Bodies under the Medical Devices Directive 93/42/EEC. On 9th April 2015 the German court decided to refer a liability case involving a breast implant dispute to the CJEU and has asked the CJEU to provide clarification on the interpretation of Notified Body liability for medical devices in the EU. Read more
On April 14th 2015 Members of the Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI) approved an Opinion on recommendations to the European Commission on the negotiations for the Transatlantic Trade and Investment Partnership (TTIP). They voted in favour of the exclusion of five health-related topics from the TTIP negotiations between the EU and the United States. Read more
On April 10th 2015, two new EU Restriction of Hazardous Substances exemptions were published in the Official Journal of the EU.
These two new exemptions, along with the expiration dates, are applicable to “Medical devices” and “Monitoring and control instruments including industrial monitoring and control instruments” category 8 and 9 of the Annex IV to RoHS Directive 2011/65/EU.
Are you aware of what substances and until when their usage was exempted? Check it out below!
On the 12th January 2015, the European Commission published the results of the consultation on the Green Paper on mobile health. Public Authorities, healthcare providers, patients’ organisations and web entrepreneurs, inside and outside the EU, gave feedback on eleven issues related to the uptake of mobile Health (mHealth) in the EU. Read more
On March 5th 2015 the Court of Justice of the European Union published its Decision in In Joined Cases C‑503/13 and C‑504/13, concerning pacemakers and Implantable Cardioverter Defibrillators.
Reform of the Medical Device regulatory framework, where are we?
Published for the first time in 2012, the EU Commission’s proposal is stuck as EU Member States cannot agree on key point of the file. Read more
The Medicines and Healthcare Products Regulatory Agency (MHRA) regulates medicines and medical devices in the UK. Together with other National Authorities, they started a pilot project on the implementation of an EU vigilance reporting portal for medical devices. Read more
According to recent reports, it appears clear that the future Transatlantic Trade and Investment Partnership (TTIP) between the European Union and the United States will most likely entail a higher level of reciprocal recognition and an easier circulation of Medical Devices between the two sides of the Atlantic.
Following the conclusion of the 6th and 7th rounds of negotiations, held respectively in July 2014 and October 2014, it seems clear that both, the European Union and the United States are eager to work towards recognising each other’s procedures for the approval and control of Medical Devices and to improve their cooperation in this area.
The European Commission has published the new list of European standards relating to medical devices.
On 16th of January 2015 The European Commission published a number of Communications providing an updated list of harmonized standards in the framework of the following Council Directives:
On December 1st 2014 The European Council took note of the progress report of the Italian presidency on the two proposals for new regulations on medical devices and in vitro diagnostic medical devices.
The report noted that considerable progress has been achieved on these files under the Italian presidency. However, further discussions are needed for the Council to agree its position.
The European Commission asked the Scientific Committee on Emerging Newly Identified Health Risks (SCENIHR) for a scientific opinion to assess the safety of Metal-on-Metal (MoM) joint replacements with a particular focus on hip implants. The final opinion has been adopted on September 24th 2014.
The opinion aims to assess whether there are any health concerns linked to the use of MoM implants in arthroplasty. It also seeks, where possible, to provide indications on design of the devices, on patient groups and to identify needs for further research.
In February 2014, the International Electrotechnical Commision introduced the 4th edition of IEC 6061-1-2:2014 for medical electrical equipment. The fourth edition of this harmonized standard cancels and replaces the third edition of IEC 60601-1-2, published in 2005, and implies the significant technical revisions such as new risk analysis and immunity requirements.
The new edition may have a dramatical impact to the medical industry and presents several challenges relating to the design, EMC testing and documentation to the medical devices.
So what are the new changes? And how this new edition will affect your business? Here we look at the recent 4th Edition and its effect on the EMC Compliancefor medical devices.
The publication of the next version of ISO 13485 is postponed to 2016. Welcome ISO 13485:2016!
During the last meeting of the Technical Committee Working Group held in July, the published draft version of ISO 13485 was submitted to the vote of the Working Group members. The draft was not approved.
There will be a new round of comments / changes / approval, which makes the objective of publishing the final version in 2015 very unlikely. Read more
In April 2014, the European Commission finally published the revised Blue Guide on the implementation of EU products rules (The “Blue Guide”). This updated version of the Blue Guide reflects the modernization and harmonization of the EU legislative framework for marketing of products.
The Concept and Objectives of the revision
The New Blue Guide updates the previous edition of the Blue Guide (Guide to the implementation of the directives based on the New Approach and the Global Approach), published in 2000. Since then, as it is stated in the new Blue Guide, it has become one of the main reference documents explaining how to implement the legislation based on the New Approach, now covered by the so-called New Legislative Framework (NLF). Read more
On September the 17th 2014, the European Parliament appointed Glenis Wilmott – UK member of the Labor Party – as new rapporteur for the ongoing revision of the Medical Devices Legislation.
Mrs. Willmott will be responsible for guiding the new rules through the European Parliament as well as negotiating with the Commission and national governments within the Council. Read more
EU Commission revises 700 Old Approach directives and 27 New approach Directives
The Package of measures known as the “New legislative framework” was published in the Official Journal on 13 August 2008. The measures are designed to help the internal market for goods work better and to strengthen and modernize the conditions for placing a wide range of industrial products on the EU market.
The target of the New Legislative Framework is:
- Improve market surveillance rules to better protect consumers and professionals from unsafe products
- Boost the quality of the conformity assessment of products
- Clarify the meaning of CE marking
- Define roles of economic operators