Notified Bodies are organizations accredited by national EU competent authorities with the aim of supporting the manufacturer by carrying out conformity assessment procedures and issuing conformity certificates, thus supporting the manufacturer to affix the CE marking to their medical devices. Such conformity procedures and certificates are required under the “New Approach” Directives for medical devices – MDD 93/42/EEC, AIMDD 90/385/EEC and IVDD 98/79/EC.
What is the best way of selecting a Notified Body?
Are disinfectant products classified as medical devices?
When considering the characteristics of a disinfectant product for the purpose of product classification, manufacturers may conclude that their products fall within the scope of a medical device or an accessory to a medical device.
The MDD 93/42/EEC, Annex IX, rule 15 dictates:
– All devices intended specifically to be used for disinfecting medical devices are in Class IIa. ►M5 Unless they are specifically to be used for disinfecting invasive devices, in which case they are in Class IIb.
Promotion & advertising rules for Medical Devices by EU Directives
At many occasions, medical device professionals are faced with uncertainty and confusion when initiating promotions of medical devices. This is due to the fact that EU legislation provides little guidance and direct rules on the promotion or sampling of medical devices within the European Market
The common mistake is the assumption that such matters are not regulated – the assumption is of course erroneous as the promotion of medical devices is governed by several EU Directives, most of which are of general application, as well as the EU member states national laws implementing such Directives. Ultimately, the real challenge resides in the identification of the applicable provisions and their implementation to the specific cases.
Impact on the Authorized Representative by NEW medical device proposals
The new proposal on medical devices and the new proposal on in-vitro diagnostics medical devices as presented during the press conference of September 26th 2012, by the EU Commissioner for Health and Consumer Policy, John Dalli bring important changes to the role & responsibilities of the authorized representative.
Obelis officially welcomes NEW Proposals of European Medical Device Legislation
Obelis European Authorized Representative Center (O.E.A.R.C.), 24 years in business and operating as one of the largest regulatory centers in Europe today, providing CE marking advisory services and European Authorized Representative services – officially welcomes the new proposals for new regulations on medical devices and in-vitro diagnostics medical devices as presented during the press conference, by the EU Commissioner for Health and Consumer Policy, John Dalli.
Review of Press Conference on NEW Proposals of European Medical Device Legislation
With over 500,000 medical devices on the European market and the recent PIP fraud incident, amending the current European legal frame work on medical devices was inevitable;
On the 26th of September 2012, Mr. John Dalli, EU Commissioner for Health and Consumer Policy, presented in a 25 minute press conference of September 26th 2012, the main principles within the proposals for new regulations for medical devices and in-vitro diagnostics medical devices adopted by the European Commission.
Eucomed welcoming medical device proposals with reservations
Eucomed, the European medical technology industry association has expressed its welcome to the adoption of the proposals for new regulations for medical devices and in-vitro diagnostics medical devices by the European Commission.
Update on Medical Device Regulations in Switzerland
The European Economic Area (EEA) is formed by the 27 member states of the European Union as well as the 3 EFTA countries, Iceland, Norway & Lichtenstein (view map of the EEA ) – as such, one can wonder, what is the status of Switzerland within this league of nations and how medical devices are regulated in this market?
Commission Proposal for a NEW REGULATION on Medical Devices and In-Vitro Diagnostic Medical Devices
On 26th Sept, 2012 the Commission has adopted a Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and a Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on in vitro diagnostic medical devices as announced during the press conference by John DALLI, Member of the EC in charge of Health and Consumer Policy.
The EU Regulation 722/2012 on utilizing tissues of animal origin
The EU Regulation 722/2012 on AIMDD 90/385/EEC and MDD 93/42/EEC utilizing tissues of animal origin was published in the Official Journal L212 on 09 August 2012, entered into force on the 28 August 2012 and applicable from 29 August 2013. As a regulation, it does not need to be transposed into national legislations by the individual EU states.
NEW WEEE Directive’s Affects on Medical Devices
How does WEEE apply to Medical Devices?
As opposed to the WEEE Directive 2002/96/EC & 2003/108/EC, which states that Medical Devices (regulated under MDD 93/42/EEC, IVD 98/79/EC, AIMDD 90/385/EEC falling under WEEE do not require achieving any recycling collecting target, the repealing WEEE Directive 2012/19/EU tightens the legislation and sets tangible objectives:
- From 13th August 2012: Medical Devices are subjects to a recovery target of 70% and a recycling target of 50%;
- From 15th August 2015: Medical Devices are subjects to recovery target of 75% and a recycling target of 55% respectively;
- From 15th August 2015: Medical Devices (falling under category 4: Large equipments) are subjects to recovery target of 85% and a recycling target of 80% respectively; and Medical Devices (falling under category 5: Small equipments) are subjects to recovery target o 75% and a recycling target of 55% respectively;
The above indicated objectives make all Medical Device manufacturers, distributors, vendors and consumers take the necessary steps, if necessary, to fulfill the new WEEE requirements.
New WEEE Directive 2012/19/EU (Waste of Electric & Electronic Equipments) is published
What is the objective?
The utmost aims of the WEEE Directive are to reduce the amount of waste electrical and electronic equipment that piles up in landfills and to enhance a more efficient environmental protection. The Official Journal of the European Parliament has published the NEW WEEE Directive 2012/19/EU on 24 July 2012; nearly ten years after the first WEEE Directive 2002/96/EC & 2003/108/EC
Post Marketing Surveillance on Medical Devices – US FDA Working Groups
Two public meetings were organized by the United States Food & Drug Administration (FDA) on post market Surveillance System and the good use of registries in post market.
The 1st meeting was held on September 10th, 2012 with the purpose to solicit public feedback regarding FDA’s proposal to strengthen the national medical device post market surveillance system.
The 2nd meeting took place on the 12th and 13th September 2012. The purpose of this meeting was to discuss best practices for use of registries with medical device data for post market surveillance, clinical studies, and evidence appraisal.
New lists of harmonized standards for medical devices published by EU Commission
On August 30th 2012, The EU Commission released 3 new lists of EU Harmonized Standards for medical devices under the Medical Device Directives (MDD 93/42/EEC, IVD 98/79/EC, AIMDD 90/385/EEC).
Cyprus took over EU Presidency – The role of the EC Rep
The role of the rotating Presidency of the Council of the European Union is, from time to time, not perfectly clear even for a European Member State not even mentioning a non-EU country, to whom it may appear as a function without any effects.
The reality is, however, the contrary. The Presidency’s role and activity during the 6 months can have a significant impact on both EU and non-EU members.
Revision of the IEC 60601-1 Regarding Medical Devices, 3rd Edition
The International ICE 60601-1 standard and its 3rd revision regarding the safety and effectiveness of medical electrical equipment are of crucial importance to the manufacturers of such medical devices. More so since the 3rd revision will come into force starting the 1st of June 2012.
Medical Devices in Distribution Channel Complying with IEC 60601-1, 3rd edition?
Manufacturers incorporating electric components to medical devices may find a dilemma when addressing the conformity to the 3rd edition of the IEC 60601-1, in reference to medical devices already on the distribution channel or such devices about to be shipped out of the factory. What does the standard mean? What do you have to do as manufacturers of medical devices and systems to still be able to distribute your products on the European Market come June 2012 (when the 3rd edition of IEC 60601-1 shall be fully applicable).
New Electronic Labeling for Medical Devices
A new Regulation (EU 207/2012) on electronic instructions for use of medical devices has been recently adopted by the European Commission and it will come into full force starting 1st of Marc 2013.
Apart from the CE marking affix requirements and the designation of a European Authorized Representative (EAR) for all non-EU manufactures of medical devices underlined by the MDD 93/42/EEC and AIMDD 90/385/EEC, the new Regulations brings several instructions for manufacturers on how to make available the electronic labels of products.
New Agency for Medical Device Registration in France
On April 29th 2012, France published in its official journal about the creation of a new agency, the National Agency for the Safety of Medicines and Health Products (MSNA), aimed to replace entirely its current regulatory agency, Afssaps, within a few months.
Registration TAX on Medical Devices Cancelled by Italian MoH
Since 2007, all classes of medical devices to be sold on the Italian territory are to be registered with the Italian Ministry of Health Database allowing them access to the public and private sectors (Class I devices are exempt unless required to be sold to the public sector, in which case, they must be registered as well).
As of January 24th, 2012, a new rule was introduced, waiving the required 100 Euros Registration Tax on medical devices registered in Italy. This was mainly due to the increase of 5.5% of the fee for promotional expenses. This new law came into force upon its publication in the Gazzetta Ufficiale, on the 23rd of March, 2012.
Medical Devices Workshop in Sao Paulo by EG Mont & Obelis
With a collaboration of over a decade, OBELIS and its Representative in Brazil, EG MONT, are proud to launch a resourceful workshop on the 23rd of May, 2012 in Sao Paulo.
As a special support to manufacturers exhibiting or visiting Hospitalar 2012 the Workshop will cover current issues and processes on the implementation of EU directives, EU harmonized standards and detailed steps to be taken by manufacturers in order to attain the CE marking affixed on their medical devices.
European Parliament Issued a Resolution on PIP
The PIP resolution (Poly Implant Prothese, the French company that manufactured substandard breast implants) which was proposed by The Environment and Public Health (ENVI) Committee of the European Parliament was recently adopted with a unanimous vote.
Obelis Obtains ISO 13485:2003 Certification
In addition to the ISO 9001:2008 certificate obtained since May 2001, Obelis European Authorized Representatives Center (O.E.A.R.C.) has obtained its ISO 13485:2003 certification in April 2012, attesting to the high level of quality services provided to its clients.
ISO 13485:2003 sets prerequisites for quality management systems, evidence to a company’s capacity to manufacturer medical devices and/or provide related services aimed at consistently meeting customer and regulatory requirements.
New MEDDEV 2.12-1/rev7 on Vigilance Systems published
The new MEDDEV 2.12-1/rev7 Guidance document released in March 2012 has updated the requirements related to the European system for the notification and evaluation of incidents and field safety corrective actions (FSCA) involving medical devices. The revised guidance will be applicable as of June 15th 2012.
New MEDDEV on Authorized Representatives
The EU Commission released a new guidance document for the European Authorized Represenatives (EAR) last month relating to questions of application of the EC-Directives on Medical Devices.
This new document sets important guidelines for the EARs in respect to two features:
- It summaries the roles and responsibilities of the Authorized Representative as mentioned in the medical devices Directives (MDD/93/42/EEC; AIMDD 90/385/EEC; IVDD 98/79/EC)
- It also describes the expectations of the European Union Member States regarding the role of the EAR concerning market surveillance.
Obelis s.a. @ MEDICA 2011 – Event Overview
For the last 40 years Medica Exhibition is being a definite event for the medical sector that is organized each year in Düsseldorf, Germany. In November, 2011 Obelis has attended at Medica Exhibition for the 9th consecutive year with a highly dedicated team, represented by the company’s Management:
• Mr. Gideon Elkayam – C.E.O.;
• Mr. Doram Elkayam – C.O.O.;
• Dr. Peter Ruys – Expert consultant in International Medical Device regulations;
• Mr. Hemi Zimmerman – Israeli Branch Manager;
• Ms. Stacy Edelen – USA Branch Manager.
Animal by-products EU regulation on Medical and Cosmetic products
Regulation EC 1069/2009 and its implementing Commission Regulation 142/2011 – in effect as of 4th March, 2011 – lay down the public and animal health rules for animal-by-products (ABPs) and derived products to prevent and minimize risks to health deriving from these products.
By definition: ‘animal by-product’ means entire bodies or parts of animals, products of animal origin or other products obtained from animals, which are not intended for human consumption (Article 3). These include: fallen stock on farms, wild animals when they suspected of being diseases, slaughterhouse waste, skins, feathers, blood, or meat, fish, milk and eggs when they are interned for human consumption. (Article 8, 9, 10);
Due to the increasing number of incidents, when serious diseases (TSE, BSE, swine fever) started to spread in a consequence of the lack of risk control, the preceding Regulation (EC 1774/2002) has been thoroughly revised. As a result, the current Regulation:
- Gives a more comprehensive scope and more apparent framework to the Regulation;
- Defines animal-by-products in a more transparent way;
- Clarifies the products exempted from the control of this Regulation;
- Improved the categorization of ABPs in line with risks:
- Category 1 material (e.g. animals killed in the context of TSE eradication measures)
- Category 2 material (e.g. manure, non-mineralized guano and digestive tract content)
- Category 3 material (e.g. carcasses and parts of animals slaughtered)
Consequently, the Regulation provides a greater overall legal certainty for the given substance. It has an impact on any person or business using, disposing, storing, handling or transposing animal-by-products.
Applicability for Medical Devices, In-vitro diagnostic medical devices & Cosmetics
One the most significant change that the Regulation introduces is the concept of end point in the manufacturing of animal by-products, beyond which the processed products are no longer subject to the requirements of the Regulation, due to the eliminated potential risks via heat or chemical substances. (Article 5 /Rec.22). Consequently, certain finished products such as cosmetics, medical devices and in vitro diagnostic kits are excluded from the scope of Regulation 1069/2009 in this way to reduce operational burdens, e.g. labeling or record-keeping.
The following derived products may be placed on the European market, regulated by certain Community legislation other than that of Regulation 1069/2009 (see Article 33):
- Cosmetic products as defined in Article 1(1) of Directive 76/768/EEC – See Compliance Page;
- Active implantable medical devices as defined in Article 1(2)(c) of Directive 90/385/EEC – See Compliance Page;
- Medical devices as defined in Article 1(2)(a) of Directive 93/42/EEC – See Compliance Page;
- In-vitro diagnostic medical devices as defined in Article 1(2)(b) of Directive 98/79/EC – See Compliance Page;
According to Article 34 importing, collecting animal-by-products for manufacturing the above mentioned devices, their respective Directives should be taken into account. Should not these Directives provide steps to control potential risks deriving from animal-by-products then Regulation 1069/2009 shall be applicable. However, intermediate products intended for the manufacture of medical products, veterinary medicinal products, medical device, active implement medical devices, in vitro diagnostic medical devices or laboratory reagent are subject to the obligations imposed by Regulation in question.
To conclude the above, Regulation 1069/2009 and Commission Regulation 142/2011 does not apply to finished products under the respective scopes of the:
- Scope of MDD 93/42/EEC
- Scope of AIMDD 90/385/EEC
- Scope of IVDD 98/79/EC
- Scope of Cosmetics under the 76/768/EEC and repealing regulation EC 1223/2009,
Since they are not considered as ‘animal by-products not intended for human consumption’. Therefore; they are not subjected to any veterinary checks under Council Directive 97/78/EC that lays down the principles governing the organization of veterinary checks on products entering the Community from third countries.
EU Regulation on Animal by-products affects Medical Devices & Cosmetics
Regulation 1069/2009 and Commission Regulation 142/2011 does not apply to finished products under the respective scopes of the:
- Scope of MDD 93/42/EEC
- Scope of AIMDD 90/385/EEC
- Scope of IVDD 98/79/EC
- Scope of Cosmetics under the 76/768/EEC and repealing regulation EC 1223/2009,
Since they are not considered as “animal by-products not intended for human consumption”. Therefore; they are not subjected to any veterinary checks under Council Directive 97/78/EC that lays down the principles governing the organization of veterinary checks on products entering the Community from third countries.
To review the complete analysis under our publication page – Click here;
EU Regulation & CE Marking Workshop in Sao Paulo, BRAZIL
Obelis is pleased to announce that EG MONT, Obelis’ Official Representative in Brazil, in association with HI-POWER, MEDLAB, and CENIC will be conducting a workshop in Sao Paulo, Brazil concerning the application and revisions of the CE marking as pertaining to the current European Union Directives. This workshop will focus on the CE marking as it applies to Medical Devices, In-Vitro Diagnostic Devices and how the Waste Electrical and Electronic Equipment (WEEE) and the Restriction of Hazardous Substances (RoHS) Directives influence such devices to be placed onto the European Market.
How are Products That are Considered Both Medicinal and Cosmetic Classified?
Summary of the Guidance Document:
The “Guidance Document of the Demarcation between the Cosmetic Products Directive 76/768/EEC and the Medicinal Products Directive 2001/83 as agreed between the Commission Services and the Competent Authorities of the EU Member States” document attempts to provide guidance for the classification of products that may simultaneously fulfill the definition of a cosmetic product (as per the 76/768 Directive) as well as the definition of a medicinal product (as per the 2001/83 Directive).
EU Market, Timeline & Harmonization
EU Market Timeline:
1. The European Community (1957)
2. Schengen Visa area (1985)
3. Unified European Market (1992)
4. “New Approach” (1985,1989,1993 & 2010)
5. The Euro born (2002)
Italy Registration Update: Class I Medical Devices
According to Italy’s Decree of Feb. 20, 2007, all classes of medical devices introduced in Italy after May 1, 2007 must be registered in the Italian Ministry of Health Database. It has been confirmed by the Italian Ministry of Health that manufacturers of Class I Medical Devices with an EC Rep established outside of Italy are not obligated to complete such registration.
While this may seem to be an improvement to the current system for Class I manufacturers, it is not necessarily in their best interest. If a manufacturer decides not to register its Class I device, the device is only authorized to be sold in the private sector, thus drastically reducing market potential and sales. With Class I registration, devices may be sold to both the public and private sectors.
Commission Decision on the European Databank on Medical Devices
Commission Decision of 19 April 2010 on the European Databank on Medical Devices.
Articles 5 and 6 – Competent Authorities will have just under 2 years (until 30 April 2012) to enter information on manufacturers, ARs and devices for all medical devices currently on the market and those going on until 1st May 2011.
Obelis International Offices Convention
Obelis has launched its new International Offices and will be hosting EROMED at its home offices in Brussels, Belgium.
EROMED is a 2 day workshop exclusively aimed at Obelis International Offices (O.I.O) network – providing regulatory updates, knowledge & expertise and promoting Obelis European Authorized Representative Center (O.E.A.R.C.) services in their global markets.
The Workshop is organized by Obelis s.a European Authorized Representative Center & GiDoS s.p.r.l in association with INTERTEK. Presentations will be given by experts in their fields about the latest developments in the European Regulatory framework concerning Medical Devices, In-Vitro Diagnostics, Cosmetic products, and others, with a special emphasis on the recent implementations of the 2007/47/EC, as of March 21st, 2010 (MDD), and the EC 1223/2009, as of November 30th 2009 (Cosmetics).
EROMED workshop in Sao Paulo a Success!
EROMED, held on 24 May 2010, in Sao Paulo, Brazil was a great success thanks to our cooperation with EG MONT of Brazil, and HI-POWER, a Brazilian company representing the Czech Notified Body ITC in Brazil.
The workshop involved over 40 participants, including a representative of ABIMO, the Brazilian Association of Medical Devices Manufacturers .
New Guidance on classification has been published
Legal Challenges at time of Non-Renewal of a CE certificate
By Dr. Peter N. Ruys – Senior Regulatory Expert for Obelis s.a.
In order to place a medical device on the European Market a manufacturer needs to be in conformity with the applicable European regulation. In this case in compliance with the Medical Device Directive.
One of the requirements for upper Class devices (Class IIa, IIb or III) is to obtain a CE certificate issued by a European Notified Body – the CE certificate has a time and activity related validity. Based upon his certificate the manufacturer is allowed to place medical devices in the European market.
What happens if the CE certificate is NOT renewed?
1. Is the manufacturer allowed to place NEW devices on the market?
2. What about the existing devices already on the market? Should the manufacturer recall his devices? What are the manufacturer’s responsibilities?
3. Can the manufacturer change his claim and therefore affix the CE marking based on another Directive?
Obelis Senior Regulatory Expert, Dr. Peter Ruys provides his view on these important questions;
New Portuguese National Law Transposing the 2007/47/EC announced
The Portuguese Health Products Directorate (Infarmed – Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.) announced this week that the new national Decree-Law 145/2009 transposing the European Directives for medical devices (Dir 93/42/CEE and 90/385/CEE) came into force as of March 21st 2010.
Medical Devices to Comply with the PPE 89/686/EEC
By the 2007/47/EC which came into full force as of March 21st 2010, face masks may have to comply from with the essential safety requirements of the MDD 93/42/EEC as Class I medical devices AND also with the essential safety requirements of the PPE 89/686/EEC.
Obelis launches “EROMED” Workshop
EROMED is a 2 day workshop exclusively dedicated to the NEW European regulation imposed by the 2007/47/EC. The Workshop is organized by Obelis s.a European Authorized Representative Center & GiDoS sprl in association with MDC Medical Device Certification GmbH a German Notified Body, the Israeli Chamber of Commerce and the Israeli Export Institute. You will be taught by experts in their fields about the latest developments in the European Regulatory framework concerning Medical Devices in reference to the upcoming implementation deadline of March 21st 2010 by the 2007/47/EC.