On “Pharma Blog”, Diapharm’s corporate blog, members of our staff discuss the current developments and regulatory challenges they face in their areas of expertise. The wide range of topics we cover makes it clear what we are: specialised generalists.
| Diapharm GmbH & Co. KG
| Diapharm GmbH & Co. KG
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Happy New Year 2025
| Diapharm GmbH & Co. KG
| Diapharm GmbH & Co. KG
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A milestone contribution to ensure consistent quality in GMP audits.
| Diapharm GmbH & Co. KG
| Diapharm GmbH & Co. KG
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Happy New Year 2024
| Diapharm GmbH & Co. KG
| Diapharm GmbH & Co. KG
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... last chance ...
| Diapharm GmbH & Co. KG
| Diapharm GmbH & Co. KG
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35 Years Diapharm
| Diapharm GmbH & Co. KG
| Diapharm GmbH & Co. KG
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Sommerfest 2023
| Diapharm GmbH & Co. KG
| Diapharm GmbH & Co. KG
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Momentum 2023
| Diapharm GmbH & Co. KG
| Diapharm GmbH & Co. KG
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Happy New Year - 2023
| Diapharm GmbH & Co. KG
| Diapharm GmbH & Co. KG
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Diapharm is growing… Now also in Münster!
| Diapharm GmbH & Co. KG
| Diapharm GmbH & Co. KG
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NEWS! Frankfurt office
| Diapharm GmbH & Co. KG
| Diapharm GmbH & Co. KG
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Diapharm has obtained the first MDR certificate risk class III
| Diapharm GmbH & Co. KG
| Diapharm GmbH & Co. KG
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| https://diapharm.co-operate.net
Probiotic Medical Devices lose their market
| Diapharm GmbH & Co. KG
| Diapharm GmbH & Co. KG
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| https://diapharm.co-operate.net
Borderline between medical devices and medicinal products – MDCG Guideline 2022-05 unsettles the market
The MDCG Guideline 2022-05 (Demarcation Guideline), published on 26.04.2022, aims to provide a harmonised interpretation throughout Europe of Regulation (EU) 2017/745 on medical devices (MDR) regarding the demarcation of medical devices and medicinal products.more >>
| Dr. Guido Middeler
| Diapharm GmbH & Co. KG
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| https://diapharm.co-operate.net
Access to the Swiss medical device market
Diapharm has set up a branch office in Switzerland, allowing it to act as a Swiss authorised representative for registration procedures and safety-related matters for the marketing and distribution of medical devices within the country’s borders.more >>
| Diapharm GmbH & Co. KG
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| https://diapharm.co-operate.net
Post Brexit: Notified bodies in the UK no longer issue CE certificates
For medical devices made by British manufacturers that want to remain marketable in the EU, the last-minute Brexit deal has not brought any relief: As of 31 December 2020, British Notified Bodies are no longer allowed to issue CE certificates. For medical devices of class IIa, IIb and III, however, these certificates are a prerequisite for access to the European market. Conversely, certificates from notified bodies from the EU will soon no longer be recognised in the UK.more >>
| Dr. Guido Middeler
| Diapharm GmbH & Co. KG
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| https://diapharm.co-operate.net
After Brexit: UKCA isolated solution for medical devices
The transitional temporary permissions regime for Brexit will expire before the MDR takes effect on 26 May 2021. This means that the MDR will not automatically be incorporated into existing UK law. Instead, the UK government will adopt a separate law – the Medicines and Medical Devices Bill – which will require all medical devices to be registered in the UK beginning 1 January 2021. The grace periods are short and are based on risk classes.more >>
| Dr. Bernhard Weber
| Diapharm GmbH & Co. KG
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| https://diapharm.co-operate.net
Medical protective masks – Diapharm lends its support with medical devices
Medical protective masks have become a much sought-after product during the global coronavirus pandemic. These masks are particularly needed in healthcare facilities caring for COVID-19 patients. A distinction is made between medical face masks, which patients wear to prevent them from infecting others, and personal protective equipment (FFP2 and FFP3 masks), which protects the wearer of the mask. Policymakers are forcing the establishment of domestic mask production in Germany, but imports will likely remain necessary in order to continue to meet the already foreseeable demand. However, manufacturers and distributors must keep an important date in mind: From 26 May 2021 at the latest, all medical face masks placed on the market in the EU for the first time must comply with the new Medical Device Regulation (MDR).more >>
| Dr. Guido Middeler
| Diapharm GmbH & Co. KG
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| https://diapharm.co-operate.net
MDR date of application postponed; MDD remains in force
The European Parliament and the European Council have finally agreed to the EU Commission’s proposal to delay the date of application of the MDR by one year until 26 May 2021. The announcement has already been published in the Official Journal. Manufacturers of medical devices now have more planning security again. Products that have been on the market according to the “old” standards of the Medical Device Directive (MDD) and are not yet MDR-compliant are given another chance. In addition, the Medical Device Coordination Group (MDCG) and the EU Commission have a little more time to prepare comprehensive and target-oriented guidelines for the implementation of the MDR.more >>
| Diapharm GmbH & Co. KG
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| https://diapharm.co-operate.net
Trend in phytopharmaceuticals: international regulatory extension!
Pharmaceutical companies are increasingly extending the markets for their herbal medicinal products into other EU states, for example using the decentralised procedure (DCP) or mutual recognition procedure (MRP). There is currently particularly high demand for products in the indication areas of women’s health, pain and prevention, and sedation and sleep. No wonder, because the path to new markets is very short – if you are familiar with the regulatory procedures...more >>
| Dr. Guido Middeler
| Diapharm GmbH & Co. KG
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| https://diapharm.co-operate.net
MDR postponed, problem unsolved
On 25 March 2020, the European Commission said it was looking to postpone the MDR application date by one year. As welcome as this announcement may be, nothing has happened yet apart from simply releasing a statement. Without knowing when or how the MDR will ultimately need to be applied, the industry faces an impasse when it comes to preparation.more >>
In uncertain and challenging times, mindfulness, proactive planning and the willingness to work with unconventional solutions are particularly valuable qualities. We at Diapharm continue to be there for you as a reliable partner – even though we currently cannot meet face to face with our clients. more >>
| Dr. Stefan Stromeier
| Diapharm GmbH & Co. KG
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| https://diapharm.co-operate.net
Quo vadis cannabis?
By now, many companies in Germany have applied to their local regulatory authorities, depending on where they have their registered office, for an import permit or wholesale distribution authorisation. Some are currently preparing to file the application or are considering moving into this area. While preparing their applications, these companies will face a disparate range of requirements from the competent authorities in their respective federal states.
Following intense preparation, official reviews and initial inspections of the companies’ QM systems and supply chain, many of these import permits and wholesale distribution authorisations will be granted without any major issues.
In some cases, however, there may be some unwelcome surprises…more >>
| Diapharm GmbH & Co. KG
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Nitrosamines: EMA publishes list of potential contamination sources
Marketing authorisation holders (MAHs) currently need to test all chemically synthesised medicinal products for nitrosamine contamination. This requirement extends to innovative products, generics and over-the-counter (OTC) products alike. The EMA recently released a list of potential sources of nitrosamine impurities that can help MAHs to identify risks in the manufacturing process.more >>
| Diapharm GmbH & Co. KG
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Nitrosamine: MAHs have only six months of time remaining
Since contamination with nitrosamines caused recalls of yet another substance class a few days ago, the EMA has been concerned as to how far the range of nitrosamine-contaminated medicinal products extends and which products could still be susceptible to such contamination. It intends to obtain an assurance from every Marketing Authorisation Holder (MAH) that no nitrosamines are contained in finished products. MAHs should perform a risk assessment for all of their products within the next six months.more >>
| Dr. Guido Middeler
| Diapharm GmbH & Co. KG
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| https://diapharm.co-operate.net
Increasing scarcity of notified bodies for medical devices – act now!
Medical device manufacturers who used to be able to rely on their notified body may soon find themselves without products. Manufacturers of medical devices composed of substances and combinations of substances that are being reassigned from class I to a higher medical device class are especially hard hit. They need product certification by a notified body for the first time, along with an audit of the quality management system according to EN ISO 13485:2016. But of formerly more than 80 notified bodies in Europe, many are no longer obtaining accreditation according to the MDR, which means they can no longer carry out such conformity assessments. Diapharm can help!more >>
