Last week Paola Sangiovanni and Flavio Monfrini participated, as speakers, to a webinar on the implementation of the MDR and IVDR.
The webinar was hosted by the firm Axon Lawyers based in Amsterdam and was especially interesting as members of the Alliance of European Life Sciences Law Firms in France, UK, Germany, Belgium, Greece, Spain, Belgium and The Netherlands contributed their expertise.
If you have missed it, worry not: you can find its registration here .
Save the date for Friday 18 November from 15:30 to 17:00 CET for a unique webinar about implementation of the EU MDR and IVDR in various European member states and recognition of CE marked devices on the UK market, hosted by the Alliance of European Law Firms in which medical devices legal specialists from Spain, Italy, the UK, Germany, Greece, Belgium and the Netherlands will address:
- A compare and contrast of how competent authorities in the respective countries deal with the concepts of placing on the market and making available under the MDR and IVDR, both crucial concepts for upcoming regulatory deadlines (and maybe some news on where we expect things to go with the MDR and IVDR);
- A compare and contrast of national implementing measures for the MDR and IVDR, such as regarding sanctions for non-compliance, enforcement policy and specific subjects where the MDR and IVDR allow significant local discretion (e.g. reprocessing of single use devices and as regards in-house produced devices);
- A compare and contrast of national exemption possibilities under articles 59 and 97 in view of expiring MDD/AIMDD/IVDD certificates and not timely obtain an MDR / IVDR certificate.
Do not miss out on this unique opportunity to have all your questions about medical devices and IVD regulation implementation in the UK and important EU member states addressed by our expert panel:
- Francisco Aranega from AMyS Law (Barcelona, Spain)
- Laure le Calve from LCH Avocats (Paris, France)
- An Vijverman from Dewallens & Partners (Leuven/Brussels, Belgium)
- Ioanna Michalopoulou from Michalopoulou & Associates (Athens, Greece)
- Mathias Klümper and Claudia Lützeler from Lützeler Klümper (Hamburg/Düsseldorf, Germany)
- Paola Sangiovanni and Flavio Monfrini from Gitti and Partners (Milan, Italy)
- Alex Denoon and Xisca Borras from Bristows (London, UK)
- Erik Vollebregt from Axon Lawyers (Amsterdam, The Netherlands)
If you would like to attend, please send us an email to email@example.com and we will provide you with a link and technical information on joining the seminar well in advance.
Please feel free to share this save the date with colleagues or other people that may find the seminar interesting. If they send us an email, we can send them their own link and information for joining the webinar.
Legislative Decree n. 137 of August 5, 2022 adapting Italian legislation to the MDR has been published on September 13; the decree will be in force starting from September 28, 2022. Legislative decree n. 138/2022 issues similar provisions in relation to the IVDR.
The main provisions of Legislative Decree n. 137 on medical devices are summarized here:
- Competent Authority: unsurprisingly, the Italian Ministry of Health has been designated as competent authority pursuant to Section 101 of the MDR and responsible authority for notified bodies. The Italian Ministry of Health will be in charge of:
- Resolving disputes arisen between manufacturers and notified bodies;
- Authorizing the sale of medical devices, which have not achieved full compliance, in cases of urgency and for public health or patients’ needs;
- Verifying the information rendered by manufacturers, agents and importers on Eudamed, and releasing the unique registration number;
- Surveillance activities on the implementation of the MDR;
- Receiving incident reports;
- Reporting of falsified devices.
- Custom-made medical devices: manufacturers of custom-made medical devices must notify the Ministry of Health their identifying information and the list of said devices.
- Clinical Investigations: no clinical investigation can be started without notification to the Ministry of Health. However, for Class III and invasive class IIa and IIb medical devices, clinical investigations may begin only after obtaining ministerial authorization.
- HTA: Health Technology Assessment is promoted.
- Remote selling of medical devices: in case a website is detected as a promoter of illegal practices, the Ministry of Health may issue measures in order to prevent access to the website.
- Advertisement: advertisement to the public of medical devices that (i) are custom-made, (ii) for which assistance by a healthcare professional is mandatory in accordance with applicable laws or with the manufacturer’s instructions, or (iii) require a prescription, is prohibited. Devices that are different from the foregoing may be advertised following authorization by the Ministry of Health. The Ministry of Health will issue specific decrees and guidelines on advertisement.
- Sanctions: several sanctions have been introduced (generally up to Euro 145,000).
- Medical Device Governance Fund: companies that manufacture or sell medical devices will have to disburse an annual fee equal to 0.75% of turnover, net of value-added tax, from the sale of medical devices and large equipment to the National Health Service to the fund. One third of the resources of the fund will be allocated to HTA activities.
While the decree helps aligning Italian law with the MDR, many more rules will need to be issued are delegated to the Ministry of Health and thus grey areas continue to exist.
On April 24, 2020 the new Regulation (EU) 2020/561 officially entered into force, postponing the date of application of most Medical Devices Regulation (MDR) provisions to May 26, 2021. The final text of the regulation can be found here: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32020R0561&from=EN.
The postponement was approved unanimously and was considered unavoidable since the outbreak of the covid-19 pandemic in early 2020 made it very clear that businesses, notified bodies and regulators would not be ready in time for the entry into force of the MDR requirements in May 2020.
The European Commission noted, with some relief, that “this postponement takes the pressure off national authorities, notified bodies, manufacturers and other actors so they can focus fully on urgent priorities related to the coronavirus crisis” (https://ec.europa.eu/growth/sectors/medical-devices_nn).
While the postponement might have been triggered by the covid-19 pandemic, there is no doubt it now gives regulators and the industry alike the chance to remedy the delays that have accumulated over the past few years, with the hope that they will come prepared to the new deadline of May 2021.
Still confused about the regulatory changes affecting medical devices and in vitro devices? The EU Commission has published a useful factsheet, which you can find here.
Through the factsheet, the Commission warns health institutions and healthcare professionals that the upcoming changes may have consequences on the availability of medical devices because manufacturers may decide to stop their production or because products may not get their certificates on time.
Some notified bodies have also decided to drop off and only two notified bodies have been MDR designated so far, so this will create additional bottlenecks. A short grace period until 2025 is granted, but it does not apply to class I devices.
The path to an enhanced regulatory framework will be complicated and manufacturers, healthcare institutions and healthcare professionals need to know what to expect.
Last week the PIP legal saga took another unexpected turn.
On October 10, 2018 the French Court of Cassation overturned the decision of the Appeal Court, which had cleared from liability TUV Rheinland, the notified body involved in the PIP case, and sent the case back to the Appeal Court.
Breast implants made by the French firm Poly Implant Prothèse (also known as “PIP”) had been marketed for years until, in 2010, it was discovered that silicone used for such breast implants was industrial, rather than biomedical. The investigation found that employees of PIP removed evidence of the industrial silicone gel before inspections by TUV Rheinland, the notified body who was in charge of audits on the manufacturing of the breast implants.
Breast implants are medical devices that may be marketed in the European Union if they are granted a CE marking, which is based on the certification by a notified body that the device satisfies legal requirements. The scandal, although linked to a criminal scheme, showed certain weaknesses of the medical device legislation and ultimately led to the adoption of the EU Medical Device Regulation in 2017.
PIP closed down in 2010 and, although its founder was jailed and fined, the many thousands of affected women could not be compensated by PIP. TUV Rheinland was initially condemned for negligence in 2013 and ordered to pay damages of 5.7 million euros, but was later cleared from liability by a French Appeal Court in 2015.
The Court of Cassation has now sent back the case to the Court of Appeals in order to shed light on two issues. TUV’s press release on the decision can be read here. According to Maître Cécile Derycke, Counsel for the TÜV Rheinland companies: “The TÜV Rheinland companies are serene. […] We are confident that the Court of Appeal to which the case has been referred back will confirm that TÜV Rheinland LGA Products GmbH performed its mission as a notified body diligently and in total compliance with the applicable regulations and TÜV Rheinland France SAS committed no fault.”.
Stay tuned to find out if TUV Rheinland’s is found to be a victim or a perpetrator in the PIP scandal… and if affected patients are entitled to compensation by TUV.