Current Issues on Medical Devices

The World Congress on Regulatory Affairs for Medical Devices (RAMD 2017)

/a brief review/

 

On 15 – 16 May this year Amsterdam, the Netherlands, was the host of The World Congress on Regulatory Affairs for Medical Devices (RAMD 2017. The Congress discussed various current issues on medical devices, including the traditional topics regarding the development and marketing and efficiency in medical devices, issues related to the follow-up supervision by the regulatory authorities and the key points on introduction to and compliance with the institutional requirements. Some brand new topics were presented related to medical devices, such as e-labeling and medical software.

Most of the lecturers paid a special attention in their presentation to the recently adopted regulation on medical devices in the EU, namely – Regulation (EU) 2017/745 of the European Parliament and the Council of 5 April 2017 on medical devices (MDR). The Regulation entered into force on 26 May 2017 with a transitional period of its application for three years. Unlike all currently operating directives, which each Member State is entitled to implement into their legislation in their own manner, this Regulation operates and is applicable directly in the Member States. Its adoption is part of the common EU policy focused on unification of the legislation of the different countries in order to achieve better stability, efficiency and transparency in the Union. The new legal solutions are stricter in defense of consumers, but they assume more serious financial and documentary business preparation, as well as an expectation for more severe follow-up supervision on medical devices already launched in the market.

There are a few key changes in the MDR that make it distinct from the previous legal regulations (directives).

The most significant change concerning manufacturers, merchants, importers and distributors of medical devices is the legislative decision on recertification of all medical devices. Recertification of medical devices will be done following the new rules under stricter terms and conditions, control and higher requirements to devices. A positive aspect here is the long transitional period for fulfillment of these requirements. The certificates issued by notification bodies under the directives 90/385/EEC and 93/42/EEC before 25 May 2017 (MDR became effective on 26 May 2017) will remain valid until expiry of the term indicated on the relevant certificate, except for the certificates issued in accordance with Annex 4 to Directive 90/385/EEC or Annex IV to Directive 93/42/EEC, which will become invalid on 27 May 2022 at the latest. The certificates issued by notification bodies under Directives 90/385/EEC and 93/42/EEC, as of 25 May 2017 will stay valid until the end of the period, as indicated on the relevant certificate, which does not exceeds five years after issuance. However, the certificates will become null and void on 27 May 2024. Devices that have been legally marketed under directives 90/385/EEC and 93/42/EEC before 26 May 2020, which have been launched in the market since 26 May 2020 on the basis of a certificate as mentioned above, may keep being marketed or put into operation until 27 May 2025. For example: if your medical device was launched in the market under directives 90/385/EEC and 93/42/EEC and was certified on 20 April 2017, valid for 4 years, then the certificate is valid for the entire period indicated there and is complied with the legal requirements.

Good advice for business: In case that you decide to benefit from the previous legal regulations, you had better obtain a certificate right before 26 May 2020 valid for at least four years – thus you will benefit as long as possible from the previous period. The next big change is the establishment of a unified EU database for medical devices (EUDAMED). The main objectives of EUDAMED are: informing the public about the devices launched in the market, certificates and economic operators; monitoring medical devices in the market and making their identification easier, knowledge about clinical trials and economic operators about their obligations. A positive aspect of EUDAMED is not only the better transparency for the public but helping business too.

For example – verifying a certificate or a potential partner in the database will need just to log into the system account. The term for the establishment and full functioning of EUDAMED is 26 May 2020. Now some functional rules are expected to be adopted and it is assumed to make it clear what are the obligations of the economic operators with respect to the database. A key change concerning directly all economic operators is the definition of obligations of manufacturers, authorized agents, importers, distributors and persons in charge of compliance with the legal requirements. The unclear points and gaps existing now in the legal regulation of obligations are substituted by strict rules and liabilities.

Tightening the regulatory procedures assumes more liabilities and difficulties for the economic operators. So for example, to launch a medical device in the market, device importer should check if CE marking has been placed and its EC declaration of conformity has been issued, that all necessary information is available, labeling, that the manufacturer is identifiable and if there is a designated authorized agent. In case of failure to fulfill any of the above requirements, importer will not be allowed to market the medical device at all.

In conclusion, it may be noted that the EU market of medical devices will face large challenges in the near future. It will require an action plan, strategy and a lot of work in order to keep the quality articles in the market and responsible economic operators. It will be our pleasure to accompany your business on your way to success.

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