News

Newsletter (June 20, 2010)

On March 21th 2010, the new EC Directive 2007/47/EC (which amends the MDD 93/42/EEC) became effective. Below you can find a summary of important new information, regulations and new requirements for medical device manufacturers as well for in vitro diagnostic manufacturers:

Poland, March 2010
New act on medical devices introduced in Poland
Summary: The Act paves the way for Poland to join Eudamed, an European databank for medical devices that is to become obligatory effective from 1 May 2011. The new legislation will replace an existing law of 20 April 2004, passed shortly before Poland’s entry to the EU.

Spain, March 2010
New Spanish law transposes EU medical devices legislation
Summary: The legislation RD 1591/2009 has major impact for medical device manufacturers which want to place their products on the Spanish market. It is necessary to register all medical devices into a Spanish database. The complex registration procedure concerns the following medical devices:
- All class IIa, IIb and class III medical devices (according to the Real Decreto 1591/2009 from 16th of October
- All active implantable medical devices according to the Real Decreto 1616/2009 from 26th of October
- All self testing and Annex II IVD devices according to the Real decreto 1662/2000 from 29th of September(for these kind of devices a notification was also necessary before the legislation RD 1591/2009 came into force)
MT Promedt Consulting GmbH is in the preparation for getting the official accreditation by the Spanish MoH to perform the complex registration procedure. Please do not hesitate to contact us for further questions.

Portugal, March 2010
Transposition of the 2007/47/EC into national Portuguese law
Summary: When a clinical investigation on medical devices is to take place in Portugal, the manufacturer or his authorized representative is required to submit to the Portuguese Competent Authority for medical devices, INFARMED, I.P., the clinical investigation notification which consists of several documents. One of the requested documents is of course the Ethical Committee Approval. In order to receive a favorable opinion from the Ethical Committee, the manufacturer must complete an application to the Ethical Committee as defined by the regulation No 514/2010 on the elements that should be attached to the aforementioned application.

Switzerland, April 2010
New Swiss devices law aligns with EU, adds country-specific provisions
Summary: Switzerland has incorporated into its law the European rules for reporting serious adverse events, according to the revised EU medical device guideline on vigilance (MEDDEV 2.12-1 rev. 6). The country-specific changes include: the introduction of measures to regulate, for the first time, the in-house manufacturing of in vitro diagnostics; clarification of federal and cantonal competences for compliance monitoring (e.g. the cantons are responsible for monitoring the production of custom-made devices as well as the maintenance and refurbishment of professional-use devices); and clarifications on the use of medical intense pulsed light lamps.

Patient safety: EU-wide databank for medical devices, April 2010
Summary: A European Commission decision adopted today will oblige all EU countries to use, as of May 2011, a European databank for medical devices (Eudamed). Medical devices range from life- supporting devices or X-ray machines, down to products used daily such as syringes or blood tests. The Eudamed databank is a tool which will ensure rapid access to such data by market surveillance authorities. The databank will also streamline the rules for manufacturers placing in vitro diagnostic (IVD) devices on the market.

Italy changes rules so Class I medical devices do not need to be registered if your EC REP is located outside Italy, May 2010
Summary: Changes to the registration requirements for medical devices in Italy have been enacted; namely that registration is no longer required for Class I devices that have European Authorized Representation located outside of Italy.

Common technical specifications (CTS) for in vitro diagnostic medical devices, May 2010
Summary: The common technical specifications for in vitro diagnostic medical devices (IVDMD), as amended by EC decision n. 9464/2009, were published on the Italian OJ n.123 of May 28th 2010. The specifications are listed in Annex I of the Ministry bulletin. The CTS concern all the IVDMD listed in Annex II, List A, of D.Lgs. 8 September 2000, no.332, as amended by D.Lgs. 25 January 2010 (implementation of the EU Dir. 98/79/CE and further amendments).
Other than on the OJ, the full text of the bulletin is available on the website of the Ministry of Health, on the Normativa Sanitaria page (http://www.normativasanitaria.it).

Australia makes important regulatory changes affecting medical device and IVD manufacturers, June 2010
Summary: Australia has made three important changes to the Australian medical device and IVD regulatory landscape. They include:

- IVDs are now regulated by the Australian Therapeutic Goods Administration (TGA)
- Extensive new TGA guidance on medical devices has been issued
- The process of changing Australian Sponsors has been simplified

MT Promedt Consulting - US Office Moves (04/Feb/2010)

After many successful years in Salt Lake City, Utah, the US office of MT Promedt Consulting
expands and moves to a new location:

The new address is:
MT Promedt Consulting GmbH (US Office)
c/o Mr. Marlon Berrett
41 North Rio Grande Street #100
Salt Lake City, Utah 84101
Phone:+1-801 699 0765
Fax:+1-801 546 2917
E-Mail: marlonb@worldnet.att.net

Italy Extends Registration Deadline (10/Jan/2010)

The deadline for registering medical devices with the Italian Ministry's online database has now been extended from 31 December 2009 to 31 March 2010, meaning that manufacturers will have a further three months grace before they are not allowed to sell their devices in Italy.
The registration scheme applies to devices, kits and systems covered by the Medical Devices Directive and the Active Implantable Medical Devices Directive, with the exception of custom made devices and devices intended for clinical investigations. In Vitro Diagnostic Devices are covered by a different online registration scheme.
As a German company MT Promedt Consulting is officially authorized to perform product registration in Italy for European and Non-European manufacturers.

Guidance Updates on Clinical Evaluation and Vigilance (22/Dec/2009)

The European Commission has published revised versions of two guidance documents, available on its website.
A major rewrite of MEDDEV 2.7.1 (revision 3) on the subject of Clinical Evaluation aligns the document with the Global Harmonization Task Force (GHTF) guidance on the same subject (2007) and takes into account the revisions to the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD) brought about by Directive 2007/47/EC.
A minor change to the Vigilance MEDDEV 2.12-1 (revision 6) is restricted only to technical modifications to Annex 3 (the 'Report Form - Manufacturer's Incident Report').
MT Promedt Consulting is providing full support in preparation of Clinical Evaluation and implementation of Vigilance systems according to the new MEDDEV guidelines.

EUCOMED Releases White Paper on Reprocessing (22/Dec/2009)

EUCOMED (the European medical device industry association) has released a white paper entitled 'Eucomed White Paper on the reuse of single use devices' to present the viewpoint that effective Europe-wide provisions should be introduced for the reprocessing of medical devices labelled by their manufacturers as 'single use' with an emphasis on the importance of patient-safety aspects.
The paper comments that: "In much of Europe the practice is heavily discouraged, but not universally illegal; â€¦ Current EU directives do not prevent a so-called refurbishment industry from re-selling refurbished single use devices."

New Draft Documents by GHTF (04/Dec/2009)

The Global Harmonization Task Force (GHTF) has published three draft documents for comment on its website. Two further documents in the Quality Management series have been issued, along with a discussion paper on unique device identification (UDI).
The draft guidance documents are:
SG4/N84R12:2009: Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 5: Audits of manufacturer control of suppliers;
SG3(PD)/N18R8: Quality management system - Medical Devices - Guidance on corrective action and preventive action and related QMS processes.
The discussion document is entitled GHTF/AHWG(PD1)/N2R1: Unique Device Identification (UDI) System. In addition, the minutes of the last GHTF Steering Committee meeting, held in Toronto in May 2009, are also available from the website.